Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-03 @ 6:43 AM
Study NCT ID:
NCT02118766
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2014-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, '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}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. AEs and SAEs were analyzed for safety population which included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Crisaborole (AN2728) Ointment, 2 Percent', 'description': 'Participants with mild to moderate AD applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.', 'otherNumAtRisk': 502, 'otherNumAffected': 147, 'seriousNumAtRisk': 502, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Crisaborole (AN2728) Ointment Vehicle', 'description': 'Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.', 'otherNumAtRisk': 252, 'otherNumAffected': 50, 'seriousNumAtRisk': 252, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lymphocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Myopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Xerophthalmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dental discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tooth disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Application site acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Application site discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Application site erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Application site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Application site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Application site vesicles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Medical device pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Application site folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Application site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eczema infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hand-foot-and-mouth disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Molluscum contagiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Prostate infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyoderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Staphylococcal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Viral rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Burns first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eosinophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Monocyte count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Growing pains', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Scoliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Listless', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyshidrotic eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ingrowing nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Skin erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Helicobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Viral pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Burning/Stinging: Mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Burning/Stinging: Moderate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Burning/Stinging: Severe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': "Kawasaki's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 502, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 252, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Day 29", 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2728 Topical Ointment, 2 Percent', 'description': 'Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}, {'id': 'OG001', 'title': 'AN2728 Topical Ointment, Vehicle', 'description': 'Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000'}, {'value': '25.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.038', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': 'ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants who received the study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2728 Topical Ointment, 2 Percent', 'description': 'Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}, {'id': 'OG001', 'title': 'AN2728 Topical Ointment, Vehicle', 'description': 'Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36', 'description': 'An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study that were absent before treatment or that worsened relative to pre-treatment state.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2728 Topical Ointment, 2 Percent', 'description': 'Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}, {'id': 'OG001', 'title': 'AN2728 Topical Ointment, Vehicle', 'description': 'Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 29', 'description': 'Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate and body temperature. Vital sign measurements were performed with the participant in the seated or supine position. Clinical significance of change from baseline value was determined by investigator.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Change From Baseline in Laboratory Values at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2728 Topical Ointment, 2 Percent', 'description': 'Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}, {'id': 'OG001', 'title': 'AN2728 Topical Ointment, Vehicle', 'description': 'Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 29', 'description': 'Laboratory values included: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Blood Urea Nitrogen, Creatinine, Hematocrit, Hemoglobin, Lymphocytes, Monocytes, Neutrophils, Platelets, Basophils, Eosinophils, Red blood cell count, White blood cell count, Total bilirubin and Glucose (nonfasting), Potassium, Total Protein, and Sodium. Clinical significance of change from baseline value was determined by investigator.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29", 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2728 Topical Ointment, 2 Percent', 'description': 'Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}, {'id': 'OG001', 'title': 'AN2728 Topical Ointment, Vehicle', 'description': 'Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000'}, {'value': '40.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29', 'description': 'ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Percentage of participants with an ISGA score of 0 or 1 were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants who received the study drug.'}, {'type': 'SECONDARY', 'title': "Time to Achieve Treatment Success Based on Investigator's Static Global Assessment (ISGA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2728 Topical Ointment, 2 Percent', 'description': 'Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}, {'id': 'OG001', 'title': 'AN2728 Topical Ointment, Vehicle', 'description': 'Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median time to achieve success in ISGA and its 95% confidence interval (CI) were not estimable, as fewer participants (less than 50 percent) reached success in ISGA.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median time to achieve success in ISGA and its 95% CI were not estimable, as fewer participants (less than 50 percent) reached success in ISGA.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) up to Day 29', 'description': 'Time to achieve treatment success based on ISGA was defined as the time interval between the administrations of first dose of study drug until first documentation of success in ISGA. Success in ISGA was defined as an ISGA score of clear (0) or almost clear (1) with at least 2-grade improvement from baseline. It was analyzed using Kaplan-Meier method.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants who received the study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Signs of Atopic Dermatitis (AD) at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2728 Topical Ointment, 2 Percent', 'description': 'Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}, {'id': 'OG001', 'title': 'AN2728 Topical Ointment, Vehicle', 'description': 'Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}], 'classes': [{'title': 'Erythema: Baseline (n= 503, 256)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Erythema: Change at Day 29 (n=478,228)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Induration/Papulation: Baseline (n= 503, 256)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Induration/Papulation:Change at Day 29(n=478,228)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Exudation: Baseline (n= 503, 256)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Exudation: Change at Day 29 (n=478, 228)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Excoriation: Baseline (n= 503, 256)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Excoriation: Change at Day 29 (n=478, 228)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Lichenification: Baseline (n= 503, 256)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Lichenification: Change at Day 29 (n=478, 228)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 29', 'description': 'Signs of AD included erythema, induration/papulation, exudation, excoriation and lichenification. Each sign was assessed on a 4- point scale ranges from 0 to 3, where 0= none, 1= mild, 2= moderate to 3= severe. Higher score indicates severe signs and symptoms of AD.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Intent to treat population included all participants who were randomized and dispensed study drug. Here, Number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Improvement in Pruritus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2728 Topical Ointment, 2 Percent', 'description': 'Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}, {'id': 'OG001', 'title': 'AN2728 Topical Ointment, Vehicle', 'description': 'Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.32', 'groupId': 'OG000', 'lowerLimit': '1.19', 'upperLimit': '1.60'}, {'value': '1.87', 'groupId': 'OG001', 'lowerLimit': '1.45', 'upperLimit': '2.64'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Day 29', 'description': 'Time to improvement in pruritus was defined as the time interval between the administration of first dose of study drug till the first documentation of improvement in pruritus. Improvement in pruritus was defined as achieving none (0) or mild (1) score with at least a 1- grade improvement from baseline. Severity of pruritus was assessed on 4-point numeric scale ranges from 0 to 3, where 0= none (no itching), 1= mild (occasional, slight itching/scratching), 2= moderate (constant or intermittent itching/scratching which is not disturbing sleep) and 3= severe (bothersome itching/scratching which is disturbing sleep). Higher scores indicated more severe condition. It was analyzed using Kaplan-Meier method.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Intent to treat population included all participants who were randomized and dispensed study drug. Here, 'N' signifies those participants who were evaluable for this measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AN2728 Topical Ointment, 2 Percent', 'description': 'Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}, {'id': 'OG001', 'title': 'AN2728 Topical Ointment, Vehicle', 'description': 'Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}], 'classes': [{'title': 'Baseline (n =95, 52)', 'categories': [{'measurements': [{'value': '9.6', 'spread': '6.37', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '6.52', 'groupId': 'OG001'}]}]}, {'title': 'Change at Day 29 (n =87, 44)', 'categories': [{'measurements': [{'value': '-5.5', 'spread': '5.45', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '4.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 29', 'description': "The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Intent to treat population included all participants who were randomized and dispensed study drug. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AN2728 Topical Ointment, 2 Percent', 'description': 'Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}, {'id': 'FG001', 'title': 'AN2728 Topical Ointment, Vehicle', 'description': 'Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '507'}, {'groupId': 'FG001', 'numSubjects': '256'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '503'}, {'groupId': 'FG001', 'numSubjects': '256'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '477'}, {'groupId': 'FG001', 'numSubjects': '225'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '759', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AN2728 Topical Ointment, 2 Percent', 'description': 'Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}, {'id': 'BG001', 'title': 'AN2728 Topical Ointment, Vehicle', 'description': 'Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '2-6 years', 'categories': [{'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}, {'title': '7-11 years', 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}, {'title': '12-17 years', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}, {'title': 'greater than or equal to 18 years', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '427', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '219', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '332', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent to treat population included all randomized participants who received the study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 763}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'dispFirstSubmitDate': '2016-02-16', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-12', 'studyFirstSubmitDate': '2014-04-15', 'dispFirstSubmitQcDate': '2016-03-14', 'resultsFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2014-04-17', 'dispFirstPostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-12', 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to Improvement in Pruritus', 'timeFrame': 'Baseline up to Day 29', 'description': 'Time to improvement in pruritus was defined as the time interval between the administration of first dose of study drug till the first documentation of improvement in pruritus. Improvement in pruritus was defined as achieving none (0) or mild (1) score with at least a 1- grade improvement from baseline. Severity of pruritus was assessed on 4-point numeric scale ranges from 0 to 3, where 0= none (no itching), 1= mild (occasional, slight itching/scratching), 2= moderate (constant or intermittent itching/scratching which is not disturbing sleep) and 3= severe (bothersome itching/scratching which is disturbing sleep). Higher scores indicated more severe condition. It was analyzed using Kaplan-Meier method.'}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 29', 'timeFrame': 'Baseline, Day 29', 'description': "The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants."}], 'primaryOutcomes': [{'measure': "Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Day 29", 'timeFrame': 'Day 29', 'description': 'ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from baseline.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)', 'timeFrame': 'AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36', 'description': 'An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study that were absent before treatment or that worsened relative to pre-treatment state.'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 29', 'timeFrame': 'Baseline, Day 29', 'description': 'Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate and body temperature. Vital sign measurements were performed with the participant in the seated or supine position. Clinical significance of change from baseline value was determined by investigator.'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Laboratory Values at Day 29', 'timeFrame': 'Baseline, Day 29', 'description': 'Laboratory values included: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Blood Urea Nitrogen, Creatinine, Hematocrit, Hemoglobin, Lymphocytes, Monocytes, Neutrophils, Platelets, Basophils, Eosinophils, Red blood cell count, White blood cell count, Total bilirubin and Glucose (nonfasting), Potassium, Total Protein, and Sodium. Clinical significance of change from baseline value was determined by investigator.'}], 'secondaryOutcomes': [{'measure': "Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29", 'timeFrame': 'Day 29', 'description': 'ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Percentage of participants with an ISGA score of 0 or 1 were reported.'}, {'measure': "Time to Achieve Treatment Success Based on Investigator's Static Global Assessment (ISGA)", 'timeFrame': 'Baseline (Day 1) up to Day 29', 'description': 'Time to achieve treatment success based on ISGA was defined as the time interval between the administrations of first dose of study drug until first documentation of success in ISGA. Success in ISGA was defined as an ISGA score of clear (0) or almost clear (1) with at least 2-grade improvement from baseline. It was analyzed using Kaplan-Meier method.'}, {'measure': 'Change From Baseline in Signs of Atopic Dermatitis (AD) at Day 29', 'timeFrame': 'Baseline, Day 29', 'description': 'Signs of AD included erythema, induration/papulation, exudation, excoriation and lichenification. Each sign was assessed on a 4- point scale ranges from 0 to 3, where 0= none, 1= mild, 2= moderate to 3= severe. Higher score indicates severe signs and symptoms of AD.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atopic dermatitis'], 'conditions': ['Dermatitis, Atopic']}, 'referencesModule': {'references': [{'pmid': '38206678', 'type': 'DERIVED', 'citation': 'Stein Gold LF, Tom WL, Shi V, Sanders P, Zang C, Vlahos B, Cha A. Impact of Crisaborole in Treatment-Experienced Patients With Mild-to-Moderate Atopic Dermatitis. Dermatitis. 2024 Jan-Feb;35(1):84-91. doi: 10.1089/derm.2023.0112. Epub 2024 Jan 11.'}, {'pmid': '35292919', 'type': 'DERIVED', 'citation': 'Luger TA, Hebert AA, Zaenglein AL, Silverberg JI, Tan H, Ports WC, Zielinski MA. Subgroup Analysis of Crisaborole for Mild-to-Moderate Atopic Dermatitis in Children Aged 2 to < 18 Years. Paediatr Drugs. 2022 Mar;24(2):175-183. doi: 10.1007/s40272-021-00490-y. Epub 2022 Mar 16.'}, {'pmid': '34379285', 'type': 'DERIVED', 'citation': 'Geng B, Hebert AA, Takiya L, Miller L, Werth JL, Zang C, Sanders P, Lebwohl MG. Efficacy and Safety Trends with Continuous, Long-Term Crisaborole Use in Patients Aged >/= 2 Years with Mild-to-Moderate Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Oct;11(5):1667-1678. doi: 10.1007/s13555-021-00584-y. Epub 2021 Aug 11.'}, {'pmid': '33728583', 'type': 'DERIVED', 'citation': "Thyssen JP, Zang C, Neary MP, Bushmakin AG, Cappelleri JC, Cha A, Russo C, Luger TA. Translating the Investigator's Static Global Assessment to the Eczema Area and Severity Index in Studies of Crisaborole for Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Jun;11(3):845-853. doi: 10.1007/s13555-021-00509-9. Epub 2021 Mar 13."}, {'pmid': '32574023', 'type': 'DERIVED', 'citation': 'Stein Gold LF, Takiya L, Zang C, Sanders P, Feldman SR. Demographics and Baseline Disease Characteristics of Early Responders to Crisaborole for Atopic Dermatitis. J Drugs Dermatol. 2020 Jun 1;19(6):619-624.'}, {'pmid': '32318744', 'type': 'DERIVED', 'citation': 'Silverberg JI, Tallman AM, Ports WC, Gerber RA, Tan H, Zielinski MA. Evaluating the Efficacy of Crisaborole Using the Atopic Dermatitis Severity Index and Percentage of Affected Body Surface Area. Acta Derm Venereol. 2020 Jun 11;100(13):adv00170. doi: 10.2340/00015555-3489.'}, {'pmid': '30345457', 'type': 'DERIVED', 'citation': 'Simpson EL, Paller AS, Boguniewicz M, Eichenfield LF, Feldman SR, Silverberg JI, Chamlin SL, Zane LT. Crisaborole Ointment Improves Quality of Life of Patients with Mild to Moderate Atopic Dermatitis and Their Families. Dermatol Ther (Heidelb). 2018 Dec;8(4):605-619. doi: 10.1007/s13555-018-0263-0. Epub 2018 Oct 22.'}, {'pmid': '27417017', 'type': 'DERIVED', 'citation': 'Paller AS, Tom WL, Lebwohl MG, Blumenthal RL, Boguniewicz M, Call RS, Eichenfield LF, Forsha DW, Rees WC, Simpson EL, Spellman MC, Stein Gold LF, Zaenglein AL, Hughes MH, Zane LT, Hebert AA. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016 Sep;75(3):494-503.e6. doi: 10.1016/j.jaad.2016.05.046. Epub 2016 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and efficacy of AN2728 Topical Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females 2 years and older\n* Has a clinical diagnosis of AD according to the criteria of Hanifin and Rajka\n* Has AD involvement ≥ 5% Treatable %BSA (excluding the scalp)\n* Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1\n* All female subjects of childbearing potential must use acceptable methods of contraception from the Screening Visit continuously until 30 days after stopping study drug\n\nExclusion Criteria:\n\n* As determined by the study doctor, a medical history that may interfere with study objectives\n* Unstable AD or any consistent requirement for high potency topical corticosteroids\n* History of use of biologic therapy (including intravenous immunoglobulin)\n* Recent or anticipated concomitant use of systemic or topical therapies that might alter the course of AD\n* Recent or current participation in another research study\n* Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study\n* Participation in a previous AN2728 clinical trial'}, 'identificationModule': {'nctId': 'NCT02118766', 'briefTitle': 'Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'AN2728-AD-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AN2728 Topical Ointment, 2%', 'description': 'AN2728 Topical Ointment, 2%, applied twice daily for up to 28 days', 'interventionNames': ['Drug: AN2728 Topical Ointment, 2%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching vehicle control', 'description': 'Matching vehicle control, applied twice daily for up to 28 days', 'interventionNames': ['Drug: Matching vehicle control']}], 'interventions': [{'name': 'AN2728 Topical Ointment, 2%', 'type': 'DRUG', 'armGroupLabels': ['AN2728 Topical Ointment, 2%']}, {'name': 'Matching vehicle control', 'type': 'DRUG', 'armGroupLabels': ['Matching vehicle control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Anacor Investigational Site', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}