Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-01-21 @ 1:05 PM
Study NCT ID:
NCT02764151
Status:
TERMINATED
Last Update Posted:
2020-01-27
First Post:
2016-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
First in Patient Study for PF-06840003 in Malignant Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625742', 'term': 'PF-06840003'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Part 2 of the study was not initiated. Because after reviewing efficacy, safety, PK and PD of all available data from enrolled patients, the Sponsor decided to prematurely terminate the study.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 1 year', 'description': 'The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Anal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Protein total increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Musculoskeletal 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'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Glioblastoma multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose Limiting Toxicities (DLTs) [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Day 28', 'description': 'DLTs: Any of the following adverse events (AE) occurring in the first cycle of treatment, unless there is a clear alternative explanation. Hematologic: Grade (Gr) 4 neutropenia lasting \\>=5 days; febrile neutropenia; Gr\\>=3 neutropenic with infection; Gr\\>=3 thrombocytopenia with bleeding; Gr 4 thrombocytopenia. Non-Hematologic: Any toxicity attributable to PF-06840003 that resulted in administration of less than 80% of the planned doses during Cycle 1; Gr 4 non-hematologic AE; Gr 3 AE lasting \\>7 days despite optimal supportive care; Gr 3 central nervous system (CNS) AE regardless of duration; Gr 3 QTc prolongation (QTc \\>500 milliseconds) (a DLT only if persisting after correction of any reversible causes); Concurrent aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>3\\*upper limit of normal (ULN) and total bilirubin \\>2\\*ULN.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Part 1 enrolled participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'All-causality TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 1 year', 'description': 'An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were those with initial onset or increasing in severity after the first dose of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Part 1 enrolled participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With TEAEs by Severity (as Graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Event [CTCAE] Version 4.03) [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'Grade 3 or 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 1 year', 'description': 'Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Part 1 enrolled participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '84.19'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '60.24'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '70.76'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '36.94'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '84.19'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '60.24'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '70.76'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '36.94'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '84.19'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '60.24'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '70.76'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '36.94'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 16, and 24', 'description': 'Objective response rate (ORR), defined as the percentage of patients achieving complete response (CR) or partial response (PR) as assessed by Macdonald criteria: CR: complete disappearance of all enhancing measurable and non-measurable disease on consecutive MRI at least 4 weeks apart, off steroid, sustained for at least 4 weeks; PR: \\>=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all the participants enrolled.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR) Based on the Immunotherapy Response Assessment for Neuro-Oncology (iRANO) Criteria [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '1.26', 'upperLimit': '98.74'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '6.76', 'upperLimit': '93.24'}, {'value': '33.3', 'groupId': 'OG002', 'lowerLimit': '0.84', 'upperLimit': '90.57'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '3.19', 'upperLimit': '65.09'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '1.26', 'upperLimit': '98.74'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '60.24'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '9.43', 'upperLimit': '99.16'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '3.19', 'upperLimit': '65.09'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '84.19'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '60.24'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '70.76'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '3.19', 'upperLimit': '65.09'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 16, and 24', 'description': 'Disease control rate (DCR) was defined as the percentage of patients achieving CR, PR, or stable disease (SD). Overall DCR was based on iRANO criteria: CR: complete disappearance of all enhancing measurable and non-measurable disease on consecutive MRI at least 4 weeks apart, off steroid, sustained for at least 4 weeks; PR: \\>=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; SD: does not qualify for CR, PR, or progression disease, and stable clinically.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all the participants enrolled.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hematology Laboratory Abnormalities by Severity (as Graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Event [CTCAE] Version 4.03) [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'Anemia, Grade 0', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Anemia, Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Anemia, Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hemoglobin increased, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocyte count increased, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Lymphopenia, Grade 0', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Lymphopenia, Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Lymphopenia, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lymphopenia, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils (absolute), Grade 0', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils (absolute), Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils (absolute), Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Platelets, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Platelets, Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 1 year', 'description': 'Following parameters were analyzed for hematology laboratory test: hemoglobin, platelets, white blood cell (WBC), absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, and absolute basophils. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Part 1 enrolled participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Chemistries Laboratory Abnormalities by Severity (as Graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Event [CTCAE] Version 4.03) [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'ALT, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'ALT, Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Alkaline phosphatase, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Alkaline phosphatase, Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'AST, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'AST, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'AST, Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin (total), Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine, Grade 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine, Grade 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypercalcemia, Grade 0', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Hypercalcemia, Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hyperglycemia, Grade 0', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hyperglycemia, Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Hyperglycemia, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Hyperglycemia, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hyperkalemia, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Hyperkalemia, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypermagnesemia, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Hypermagnesemia, Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypernatremia, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Hypernatremia, Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypoalbuminemia, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Hypoalbuminemia, Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Hypoalbuminemia, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypocalcemia, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Hypocalcemia, Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypocalcemia, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypoglycemia, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Hypoglycemia, Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypokalemia, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Hypokalemia, Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Hypomagnesemia, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Hypomagnesemia, Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hyponatremia, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Hyponatremia, Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hyponatremia, Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypophosphatemia, Grade 0', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Hypophosphatemia, Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 1 year', 'description': 'Following parameters were analyzed for chemistry laboratory test: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, and phosphorous or phosphate. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Part 1 enrolled participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Findings in Vital Signs [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 1 year', 'description': 'Vital signs included measurements of blood pressure and temperature (oral, tympanic, temporal or axillary). The investigator judged any clinically significant vital signs findings.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Part 1 enrolled participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Single Dose: Maximum Observed Plasma Concentration (Cmax) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 580.5 (468-693).', 'groupId': 'OG000'}, {'value': '775.0', 'spread': '37', 'groupId': 'OG001'}, {'value': '1135', 'spread': '6', 'groupId': 'OG002'}, {'value': '1407', 'spread': '23', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 991.0 (792-1190).', 'groupId': 'OG000'}, {'value': '1309', 'spread': '28', 'groupId': 'OG001'}, {'value': '1763', 'spread': '8', 'groupId': 'OG002'}, {'value': '2286', 'spread': '20', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 'Cmax of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) were observed directly from data.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'categories': [{'measurements': [{'value': '1.58', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '2.15'}, {'value': '1.51', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '2.08'}, {'value': '1.95', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.05'}, {'value': '3.02', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '4.05'}]}]}, {'title': 'PF-06840001', 'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.05', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '2.13'}, {'value': '2.05', 'groupId': 'OG002', 'lowerLimit': '1.95', 'upperLimit': '4.00'}, {'value': '3.98', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '4.05'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 'Tmax of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) were observed directly from data as time of first occurence.', 'unitOfMeasure': 'hour (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Single Dose: Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 3155 (2450-3860).', 'groupId': 'OG000'}, {'value': '4517', 'spread': '80', 'groupId': 'OG001'}, {'value': '13340', 'spread': '21', 'groupId': 'OG002'}, {'value': '17720', 'spread': '78', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 6250 (5790-6710).', 'groupId': 'OG000'}, {'value': '7626', 'spread': '66', 'groupId': 'OG001'}, {'value': '21670', 'spread': '24', 'groupId': 'OG002'}, {'value': '28250', 'spread': '71', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 'AUClast of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by linear/log trapezoidal method.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Single Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 3380 (2900-3860).', 'groupId': 'OG000'}, {'value': '5356', 'spread': '60', 'groupId': 'OG001'}, {'value': '7606', 'spread': '11', 'groupId': 'OG002'}, {'value': '8653', 'spread': '57', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 6250 (5790-6710).', 'groupId': 'OG000'}, {'value': '8999', 'spread': '49', 'groupId': 'OG001'}, {'value': '12280', 'spread': '15', 'groupId': 'OG002'}, {'value': '13910', 'spread': '52', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 'AUCtau of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by linear/log trapezoidal method.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Single Dose: Apparent Clearance (CL/F) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=1), so NA is listed. The CL/F of this 1 participant is 527.0 mL/min.', 'groupId': 'OG000'}, {'value': '751.6', 'spread': '85', 'groupId': 'OG001'}, {'value': '1561', 'spread': '40', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=1), so NA is listed. The CL/F of this 1 participant is 358.0 mL/min.', 'groupId': 'OG000'}, {'value': '454.6', 'spread': '69', 'groupId': 'OG001'}, {'value': '965.4', 'spread': '39', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 'CL/F of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Dose/Area under the concentration-time profile from time 0 extrapolated to infinite time (AUCinf). The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.', 'unitOfMeasure': 'Milliliter per minute (mL/min)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The "Overall Number of Participants Analyzed" represents the total number of participants in the treatment group in the indicated population. The "Number Analyzed" represents the number of participants contributing to the summary statistics, i.e. number of participants where CL/F was determined.'}, {'type': 'SECONDARY', 'title': 'Single Dose: Apparent Volume of Distribution (Vz/F) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=1), so NA is listed. The Vz/F of this 1 participant is 186.0L.', 'groupId': 'OG000'}, {'value': '228.4', 'spread': '27', 'groupId': 'OG001'}, {'value': '277.2', 'spread': '20', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=1), so NA is listed. The Vz/F of this 1 participant is 97.70L.', 'groupId': 'OG000'}, {'value': '129.3', 'spread': '12', 'groupId': 'OG001'}, {'value': '159.6', 'spread': '25', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 'Vz/F of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Dose/(AUC\\*kel). AUC is the area under concentration curve and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The "Overall Number of Participants Analyzed" represents the total number of participants in the treatment group in the indicated population. The "Number Analyzed" represents the number of participants contributing to the summary statistics, i.e. number of participants where Vz/F was determined.'}, {'type': 'SECONDARY', 'title': 'Single Dose: Terminal Half-Life (t1/2) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible to calculate mean (standard deviation) for insufficient number of participants (n=1), so NA is listed. The t1/2 of this 1 participant is 4.080 hr.', 'groupId': 'OG000'}, {'value': '3.773', 'spread': '1.5931', 'groupId': 'OG001'}, {'value': '2.090', 'spread': '0.45033', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible to calculate mean (standard deviation) for insufficient number of participants (n=1), so NA is listed. The t1/2 of this 1 participant is 3.150 hr.', 'groupId': 'OG000'}, {'value': '3.580', 'spread': '1.5943', 'groupId': 'OG001'}, {'value': '1.943', 'spread': '0.39273', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 't1/2 of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The "Overall Number of Participants Analyzed" represents the total number of participants in the treatment group in the indicated population. The "Number Analyzed" represents the number of participants contributing to the summary statistics, i.e. number of participants where t1/2 was determined.'}, {'type': 'SECONDARY', 'title': 'Single Dose: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=1), so NA is listed. The AUCinf of this 1 participant is 3960 ng\\*hr/mL.', 'groupId': 'OG000'}, {'value': '5549', 'spread': '85', 'groupId': 'OG001'}, {'value': '5343', 'spread': '40', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=1), so NA is listed. The AUCinf of this 1 participant is 5820 ng\\*hr/mL.', 'groupId': 'OG000'}, {'value': '9174', 'spread': '69', 'groupId': 'OG001'}, {'value': '8645', 'spread': '39', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 'AUCinf of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by AUClast + (Clast/kel), where AUClast is the area under the concentration-time profile from time zero to the time of the last quantifiable concentration, Clast is the predicted serum concentration at the last quantifiable time point estimated from the log linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The "Overall Number of Participants Analyzed" represents the total number of participants in the treatment group in the indicated population. The "Number Analyzed" represents the number of participants contributing to the summary statistics, i.e. number of participants where AUCinf was determined.'}, {'type': 'SECONDARY', 'title': 'Multiple Dose: Maximum Observed Plasma Concentration (Cmax) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 623.0 (463-783).', 'groupId': 'OG000'}, {'value': '779.3', 'spread': '9', 'groupId': 'OG001'}, {'value': '1763', 'spread': '25', 'groupId': 'OG002'}, {'value': '2474', 'spread': '66', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 580.5 (468-693).', 'groupId': 'OG000'}, {'value': '1334', 'spread': '5', 'groupId': 'OG001'}, {'value': '2810', 'spread': '24', 'groupId': 'OG002'}, {'value': '3978', 'spread': '58', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'Cmax of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) were observed directly from data.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '3.03', 'groupId': 'OG001', 'lowerLimit': '2.08', 'upperLimit': '4.07'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '2.10'}, {'value': '3.02', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}, {'title': 'PF-06840001', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '3.03', 'groupId': 'OG001', 'lowerLimit': '2.08', 'upperLimit': '4.07'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '2.10'}, {'value': '3.95', 'groupId': 'OG003', 'lowerLimit': '2.08', 'upperLimit': '8.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'Tmax of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) were observed directly from data as time of first occurence.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 6115 (3320-8910).', 'groupId': 'OG000'}, {'value': '6680', 'spread': '75', 'groupId': 'OG001'}, {'value': '12730', 'spread': '50', 'groupId': 'OG002'}, {'value': '20410', 'spread': '96', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 10780 (5950-15600).', 'groupId': 'OG000'}, {'value': '10440', 'spread': '64', 'groupId': 'OG001'}, {'value': '21020', 'spread': '50', 'groupId': 'OG002'}, {'value': '32080', 'spread': '89', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'AUCtau of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by linear/log trapezoidal method.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Multiple Dose: Terminal Half-Life (t1/2) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.58', 'groupId': 'OG000', 'lowerLimit': '4.22', 'upperLimit': '6.94'}, {'value': '2.90', 'groupId': 'OG001', 'lowerLimit': '2.16', 'upperLimit': '3.64'}, {'value': '2.68', 'groupId': 'OG002', 'lowerLimit': '2.68', 'upperLimit': '2.68'}, {'value': '2.885', 'groupId': 'OG003', 'lowerLimit': '1.97', 'upperLimit': '3.80'}]}]}, {'title': 'PF-06840001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.505', 'groupId': 'OG000', 'lowerLimit': '4.16', 'upperLimit': '6.85'}, {'value': '2.61', 'groupId': 'OG001', 'lowerLimit': '1.92', 'upperLimit': '3.63'}, {'value': '2.50', 'groupId': 'OG002', 'lowerLimit': '2.50', 'upperLimit': '2.50'}, {'value': '2.685', 'groupId': 'OG003', 'lowerLimit': '1.91', 'upperLimit': '3.46'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 't1/2 of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The "Overall Number of Participants Analyzed" represents the total number of participants in the treatment group in the indicated population. The "Number Analyzed" represents the number of participants contributing to the summary statistics, i.e. number of participants where t1/2 was determined.'}, {'type': 'SECONDARY', 'title': 'Multiple Dose: Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate mean (standard deviation) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 63.95 (11.9-116).', 'groupId': 'OG000'}, {'value': '15.85', 'spread': '21.622', 'groupId': 'OG001'}, {'value': '687.3', 'spread': '409.76', 'groupId': 'OG002'}, {'value': '1611', 'spread': '1749.7', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate mean (standard deviation) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 109.5 (20.9-198).', 'groupId': 'OG000'}, {'value': '21.75', 'spread': '27.298', 'groupId': 'OG001'}, {'value': '1079', 'spread': '587.86', 'groupId': 'OG002'}, {'value': '2308', 'spread': '2161.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'Cmin of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was observed directly from data.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Multiple Dose: Average Concentration for the Dosing Interval (Cav) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 254.5 (138-371).', 'groupId': 'OG000'}, {'value': '278', 'spread': '75', 'groupId': 'OG001'}, {'value': '1060', 'spread': '50', 'groupId': 'OG002'}, {'value': '1702', 'spread': '96', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 449.5 (248-651).', 'groupId': 'OG000'}, {'value': '435.1', 'spread': '64', 'groupId': 'OG001'}, {'value': '1755', 'spread': '49', 'groupId': 'OG002'}, {'value': '2673', 'spread': '89', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'Cav of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was observed directly from data.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Multiple Dose: Apparent Clearance (CL/F) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 431.0 (234-628).', 'groupId': 'OG000'}, {'value': '624.2', 'spread': '75', 'groupId': 'OG001'}, {'value': '327.6', 'spread': '50', 'groupId': 'OG002'}, {'value': '408.3', 'spread': '96', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 241.5 (133-350).', 'groupId': 'OG000'}, {'value': '399.1', 'spread': '64', 'groupId': 'OG001'}, {'value': '198.2', 'spread': '50', 'groupId': 'OG002'}, {'value': '259.5', 'spread': '89', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'CL/F of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Dose/Area under the concentration-time profile from time 0 extrapolated to infinite time (AUCinf).', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Multiple Dose: Apparent Volume of Distribution (Vz/F) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '184.5', 'groupId': 'OG000', 'lowerLimit': '140', 'upperLimit': '229'}, {'value': '216', 'groupId': 'OG001', 'lowerLimit': '202', 'upperLimit': '230'}, {'value': '128', 'groupId': 'OG002', 'lowerLimit': '128', 'upperLimit': '128'}, {'value': '270.5', 'groupId': 'OG003', 'lowerLimit': '269', 'upperLimit': '272'}]}]}, {'title': 'PF-06840001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '102.6', 'groupId': 'OG000', 'lowerLimit': '79.1', 'upperLimit': '126'}, {'value': '117', 'groupId': 'OG001', 'lowerLimit': '114', 'upperLimit': '125'}, {'value': '72.6', 'groupId': 'OG002', 'lowerLimit': '72.6', 'upperLimit': '72.6'}, {'value': '162', 'groupId': 'OG003', 'lowerLimit': '153', 'upperLimit': '171'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'Vz/F of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Dose/(AUC\\*kel). AUC is the area under concentration curve and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The "Overall Number of Participants Analyzed" represents the total number of participants in the treatment group in the indicated population. The "Number Analyzed" represents the number of participants contributing to the summary statistics, i.e. number of participants where Vz/F was determined.'}, {'type': 'SECONDARY', 'title': 'Multiple Dose: Observed Accumulation Ratio (Rac) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 1.725 (1.14-2.31).', 'groupId': 'OG000'}, {'value': '1.244', 'spread': '31', 'groupId': 'OG001'}, {'value': '1.670', 'spread': '45', 'groupId': 'OG002'}, {'value': '2.359', 'spread': '45', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=2), so NA is listed. The median (range) was presented for n=2: 1.680 (1.03-2.33).', 'groupId': 'OG000'}, {'value': '1.163', 'spread': '31', 'groupId': 'OG001'}, {'value': '1.717', 'spread': '45', 'groupId': 'OG002'}, {'value': '2.304', 'spread': '41', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'Rac of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by AUCtau (steady state) / AUCtau (single dose).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Multiple Dose: Steady State Accumulation Ratio (Rss) of PF-06840002 and PF-06840001 [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=1), so NA is listed. The Rss of this 1 participant is 2.250.', 'groupId': 'OG000'}, {'value': '1.289', 'spread': '37', 'groupId': 'OG001'}, {'value': '1.961', 'spread': '72', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'It is not possible and meaningful to calculate geometric mean (geometric CV) for insufficient number of participants (n=1), so NA is listed. The Rss of this 1 participant is 1.020.', 'groupId': 'OG000'}, {'value': '1.266', 'spread': '31', 'groupId': 'OG001'}, {'value': '1.895', 'spread': '61', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'Rss of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by AUCtau (steady state) / AUCinf (single dose). The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The "Overall Number of Participants Analyzed" represents the total number of participants in the treatment group in the indicated population. The "Number Analyzed" represents the number of participants contributing to the summary statistics, i.e. number of participants where Rss was determined.'}, {'type': 'SECONDARY', 'title': 'Steady-State Trough Level Ratio [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'PF-06840002', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.007', 'groupId': 'OG002'}, {'value': '1.00', 'spread': '0.692', 'groupId': 'OG003'}]}]}, {'title': 'PF-06840001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.105', 'groupId': 'OG002'}, {'value': '0.88', 'spread': '0.619', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 15', 'description': 'Steady-State trough level ratio was determined by cerebrospinal fluid (CSF)/Plasma. CSF/Plasma ratio was calculated based on the unbound concentration of each analyte. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The "Overall Number of Participants Analyzed" represents the total number of participants in the treatment group in the indicated population. The "Number Analyzed" represents the number of participants contributing to the summary statistics, i.e. number of participants where CSF/Plasma ratio was determined.'}, {'type': 'SECONDARY', 'title': 'Plasma Kynurenine and Tryptophan [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'title': 'Kynurenine', 'categories': [{'measurements': [{'value': '1.545', 'spread': '0.2051', 'groupId': 'OG000'}, {'value': '2.185', 'spread': '1.7443', 'groupId': 'OG001'}, {'value': '1.144', 'spread': '0.1479', 'groupId': 'OG002'}, {'value': '1.523', 'spread': '0.4321', 'groupId': 'OG003'}]}]}, {'title': 'Tryptophan', 'categories': [{'measurements': [{'value': '48.15', 'spread': '4.596', 'groupId': 'OG000'}, {'value': '29.55', 'spread': '4.611', 'groupId': 'OG001'}, {'value': '36.77', 'spread': '7.681', 'groupId': 'OG002'}, {'value': '33.10', 'spread': '4.590', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose, and 1, 2, 4, 6, 8, 24 hours post-dose; Cycle 1 Day 4 and Day 8 pre-dose; Cycle 1 Day 15 pre-dose, and 1, 2, 4, 6, 8, 24 hours post-dose', 'description': 'The levels of Kynurenine and Tryptophan in blood samples were determined using the qualified analytical method.', 'unitOfMeasure': 'micromolar', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the total number of participants in the treatment group in the indicated population.'}, {'type': 'SECONDARY', 'title': 'Plasma Endogenous Kynurenine/Tryptophan Ratio [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'OG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'OG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'OG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.467', 'spread': '0.6791', 'groupId': 'OG000'}, {'value': '53.066', 'spread': '24.9722', 'groupId': 'OG001'}, {'value': '25.854', 'spread': '7.6209', 'groupId': 'OG002'}, {'value': '42.463', 'spread': 'NA', 'comment': 'The number of participants in the group "PF-06840003 500 MG BID" on Cycle 1 Day 1 was 8 but the number of participants analyzed at the end of treatment was n=1. It is not possible to calculate standard deviation for n=1, therefore NA was listed.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 pre-dose, and 1, 2, 4, 6, 8, 24 hours post-dose; Cycle 1 Day 4 and Day 8 pre-dose; Cycle 1 Day 15 pre-dose, and 1, 2, 4, 6, 8, 24 hours post-dose', 'description': 'The Kynurenine/Tryptophan ratio was determined by 1000\\*Kynurenine/Tryptophan.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The "Number of Participants Analyzed" represents the total number of participants in the treatment group in the indicated population on Cycle 1 Day. The "Number Analyzed" represents the number of participants contributing to the summary statistics at the end of treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'FG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'FG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'FG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Subject refused further follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'After reviewing efficacy, safety, PK and PD of all available data from enrolled patients, the Sponsor decided to prematurely terminate the study and not to pursue marketing approval for PF-06840003 in the indication of malignant glioma. Part 2 of the study was not initiated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-06840003 125 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 125 mg once daily (QD) for 28-day cycles.'}, {'id': 'BG001', 'title': 'PF-06840003 250 MG QD', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg QD for 28-day cycles.'}, {'id': 'BG002', 'title': 'PF-06840003 250 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 250 mg twice daily (BID) for 28-day cycles.'}, {'id': 'BG003', 'title': 'PF-06840003 500 MG BID', 'description': 'PF-06840003 (formulated 125 mg tablets) was administered orally at 500 mg BID for 28-day cycles.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'spread': '19.1', 'groupId': 'BG000'}, {'value': '51.8', 'spread': '14.5', 'groupId': 'BG001'}, {'value': '49.3', 'spread': '12.1', 'groupId': 'BG002'}, {'value': '58.1', 'spread': '14.6', 'groupId': 'BG003'}, {'value': '53.5', 'spread': '14.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '18-44 Years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': '45-64 Years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': '>=65 Years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Part 1 enrolled participants who received at least 1 dose of study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-19', 'size': 8586722, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-12-02T11:15', 'hasProtocol': True}, {'date': '2017-02-28', 'size': 2314281, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-12-02T11:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Sponsor decided to prematurely terminate the study and not to pursue marketing approval for the indication of malignant glioma.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-13', 'studyFirstSubmitDate': '2016-04-27', 'resultsFirstSubmitDate': '2019-12-02', 'studyFirstSubmitQcDate': '2016-05-03', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-13', 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose Limiting Toxicities (DLTs) [Part 1]', 'timeFrame': 'Baseline to Day 28', 'description': 'DLTs: Any of the following adverse events (AE) occurring in the first cycle of treatment, unless there is a clear alternative explanation. Hematologic: Grade (Gr) 4 neutropenia lasting \\>=5 days; febrile neutropenia; Gr\\>=3 neutropenic with infection; Gr\\>=3 thrombocytopenia with bleeding; Gr 4 thrombocytopenia. Non-Hematologic: Any toxicity attributable to PF-06840003 that resulted in administration of less than 80% of the planned doses during Cycle 1; Gr 4 non-hematologic AE; Gr 3 AE lasting \\>7 days despite optimal supportive care; Gr 3 central nervous system (CNS) AE regardless of duration; Gr 3 QTc prolongation (QTc \\>500 milliseconds) (a DLT only if persisting after correction of any reversible causes); Concurrent aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>3\\*upper limit of normal (ULN) and total bilirubin \\>2\\*ULN.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Part 1]', 'timeFrame': 'Baseline up to 1 year', 'description': 'An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were those with initial onset or increasing in severity after the first dose of study treatment.'}, {'measure': 'Number of Participants With TEAEs by Severity (as Graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Event [CTCAE] Version 4.03) [Part 1]', 'timeFrame': 'Baseline up to 1 year', 'description': 'Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) [Part 1]', 'timeFrame': 'Weeks 8, 16, and 24', 'description': 'Objective response rate (ORR), defined as the percentage of patients achieving complete response (CR) or partial response (PR) as assessed by Macdonald criteria: CR: complete disappearance of all enhancing measurable and non-measurable disease on consecutive MRI at least 4 weeks apart, off steroid, sustained for at least 4 weeks; PR: \\>=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks.'}, {'measure': 'Disease Control Rate (DCR) Based on the Immunotherapy Response Assessment for Neuro-Oncology (iRANO) Criteria [Part 1]', 'timeFrame': 'Weeks 8, 16, and 24', 'description': 'Disease control rate (DCR) was defined as the percentage of patients achieving CR, PR, or stable disease (SD). Overall DCR was based on iRANO criteria: CR: complete disappearance of all enhancing measurable and non-measurable disease on consecutive MRI at least 4 weeks apart, off steroid, sustained for at least 4 weeks; PR: \\>=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; SD: does not qualify for CR, PR, or progression disease, and stable clinically.'}, {'measure': 'Number of Participants With Hematology Laboratory Abnormalities by Severity (as Graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Event [CTCAE] Version 4.03) [Part 1]', 'timeFrame': 'Baseline up to 1 year', 'description': 'Following parameters were analyzed for hematology laboratory test: hemoglobin, platelets, white blood cell (WBC), absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, and absolute basophils. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here.'}, {'measure': 'Number of Participants With Chemistries Laboratory Abnormalities by Severity (as Graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Event [CTCAE] Version 4.03) [Part 1]', 'timeFrame': 'Baseline up to 1 year', 'description': 'Following parameters were analyzed for chemistry laboratory test: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, and phosphorous or phosphate. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here.'}, {'measure': 'Number of Participants With Clinically Significant Findings in Vital Signs [Part 1]', 'timeFrame': 'Baseline up to 1 year', 'description': 'Vital signs included measurements of blood pressure and temperature (oral, tympanic, temporal or axillary). The investigator judged any clinically significant vital signs findings.'}, {'measure': 'Single Dose: Maximum Observed Plasma Concentration (Cmax) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 'Cmax of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) were observed directly from data.'}, {'measure': 'Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 'Tmax of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) were observed directly from data as time of first occurence.'}, {'measure': 'Single Dose: Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 'AUClast of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by linear/log trapezoidal method.'}, {'measure': 'Single Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 'AUCtau of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by linear/log trapezoidal method.'}, {'measure': 'Single Dose: Apparent Clearance (CL/F) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 'CL/F of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Dose/Area under the concentration-time profile from time 0 extrapolated to infinite time (AUCinf). The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'measure': 'Single Dose: Apparent Volume of Distribution (Vz/F) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 'Vz/F of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Dose/(AUC\\*kel). AUC is the area under concentration curve and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'measure': 'Single Dose: Terminal Half-Life (t1/2) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 't1/2 of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'measure': 'Single Dose: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose', 'description': 'AUCinf of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by AUClast + (Clast/kel), where AUClast is the area under the concentration-time profile from time zero to the time of the last quantifiable concentration, Clast is the predicted serum concentration at the last quantifiable time point estimated from the log linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'measure': 'Multiple Dose: Maximum Observed Plasma Concentration (Cmax) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'Cmax of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) were observed directly from data.'}, {'measure': 'Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'Tmax of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) were observed directly from data as time of first occurence.'}, {'measure': 'Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'AUCtau of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by linear/log trapezoidal method.'}, {'measure': 'Multiple Dose: Terminal Half-Life (t1/2) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 't1/2 of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'measure': 'Multiple Dose: Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'Cmin of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was observed directly from data.'}, {'measure': 'Multiple Dose: Average Concentration for the Dosing Interval (Cav) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'Cav of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was observed directly from data.'}, {'measure': 'Multiple Dose: Apparent Clearance (CL/F) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'CL/F of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Dose/Area under the concentration-time profile from time 0 extrapolated to infinite time (AUCinf).'}, {'measure': 'Multiple Dose: Apparent Volume of Distribution (Vz/F) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'Vz/F of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Dose/(AUC\\*kel). AUC is the area under concentration curve and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'measure': 'Multiple Dose: Observed Accumulation Ratio (Rac) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'Rac of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by AUCtau (steady state) / AUCtau (single dose).'}, {'measure': 'Multiple Dose: Steady State Accumulation Ratio (Rss) of PF-06840002 and PF-06840001 [Part 1]', 'timeFrame': 'Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post', 'description': 'Rss of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by AUCtau (steady state) / AUCinf (single dose). The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'measure': 'Steady-State Trough Level Ratio [Part 1]', 'timeFrame': 'Baseline and Day 15', 'description': 'Steady-State trough level ratio was determined by cerebrospinal fluid (CSF)/Plasma. CSF/Plasma ratio was calculated based on the unbound concentration of each analyte. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.'}, {'measure': 'Plasma Kynurenine and Tryptophan [Part 1]', 'timeFrame': 'Cycle 1 Day 1 pre-dose, and 1, 2, 4, 6, 8, 24 hours post-dose; Cycle 1 Day 4 and Day 8 pre-dose; Cycle 1 Day 15 pre-dose, and 1, 2, 4, 6, 8, 24 hours post-dose', 'description': 'The levels of Kynurenine and Tryptophan in blood samples were determined using the qualified analytical method.'}, {'measure': 'Plasma Endogenous Kynurenine/Tryptophan Ratio [Part 1]', 'timeFrame': 'Cycle 1 Day 1 pre-dose, and 1, 2, 4, 6, 8, 24 hours post-dose; Cycle 1 Day 4 and Day 8 pre-dose; Cycle 1 Day 15 pre-dose, and 1, 2, 4, 6, 8, 24 hours post-dose', 'description': 'The Kynurenine/Tryptophan ratio was determined by 1000\\*Kynurenine/Tryptophan.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GBM', 'malignant glioma', 'glioma', 'anaplastic glioma', 'astrocytoma', 'IDO', 'IDO1', 'PF-06840003'], 'conditions': ['Oligodendroglioma', 'Astrocytoma', 'Malignant Glioma']}, 'referencesModule': {'references': [{'pmid': '32436060', 'type': 'DERIVED', 'citation': 'Reardon DA, Desjardins A, Rixe O, Cloughesy T, Alekar S, Williams JH, Li R, Taylor CT, Lassman AB. A phase 1 study of PF-06840003, an oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor in patients with recurrent malignant glioma. Invest New Drugs. 2020 Dec;38(6):1784-1795. doi: 10.1007/s10637-020-00950-1. Epub 2020 May 20.'}, {'pmid': '30232146', 'type': 'DERIVED', 'citation': 'Gomes B, Driessens G, Bartlett D, Cai D, Cauwenberghs S, Crosignani S, Dalvie D, Denies S, Dillon CP, Fantin VR, Guo J, Letellier MC, Li W, Maegley K, Marillier R, Miller N, Pirson R, Rabolli V, Ray C, Streiner N, Torti VR, Tsaparikos K, Van den Eynde BJ, Wythes M, Yao LC, Zheng X, Tumang J, Kraus M. Characterization of the Selective Indoleamine 2,3-Dioxygenase-1 (IDO1) Catalytic Inhibitor EOS200271/PF-06840003 Supports IDO1 as a Critical Resistance Mechanism to PD-(L)1 Blockade Therapy. Mol Cancer Ther. 2018 Dec;17(12):2530-2542. doi: 10.1158/1535-7163.MCT-17-1104. Epub 2018 Sep 19.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C0591001', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and tolerability of increasing doses of PF-06840003 in patients with malignant gliomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of WHO Grade IV glioblastoma or WHO Grade III anaplastic gliomas\n* For patients with Grade IV GBM, recurrent disease at the time of the first or second recurrence or progression. For patients with Grade III anaplastic gliomas, recurrent disease at the time of at least a first recurrence but no more than a fourth recurrence or progression\n* Karnofsky performance score greater than or equal to 70%\n* Adequate bone marrow, kidney and liver function\n\nExclusion Criteria:\n\n* History of CNS bleeding within 6 months of registration\n* Previous anti-angiogenics or anti-vascular endothelial growth factor within 12 months of registration\n* Requires treatment with high dose systemic corticosteroids defined as \\>2 mg/day\n* Radiation therapy within 12 weeks of registration'}, 'identificationModule': {'nctId': 'NCT02764151', 'briefTitle': 'First in Patient Study for PF-06840003 in Malignant Gliomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06840003 IN PATIENTS WITH MALIGNANT GLIOMAS', 'orgStudyIdInfo': {'id': 'C0591001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-06840003', 'description': 'Daily Oral PF-06840003', 'interventionNames': ['Drug: PF-06840003']}], 'interventions': [{'name': 'PF-06840003', 'type': 'DRUG', 'description': 'Daily Oral PF-06840003', 'armGroupLabels': ['PF-06840003']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-6894', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Clinical & Translational Research Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Oncology Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Comprehensive Cancer Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'CUMC Research Pharmacy', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10591', 'city': 'Tarrytown', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Doctors Tarrytown', 'geoPoint': {'lat': 41.07621, 'lon': -73.85875}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center, Duke Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}