Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:28 AM
Ignite Modification Date: 2025-12-26 @ 1:02 AM
NCT ID: NCT02584634
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.
Frequency Threshold: 5
Time Frame: Baseline up to 30 days post lost dose of study treatment with a maximum of 5 years
Study: NCT02584634
Study Brief: Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A: Avelumab + Crizotinib Participants with locally advanced or metastatic Anaplastic Lymphoma Kinase (ALK)-negative non-small cell lung cancer (NSCLC) received avelumab 10 mg/kg as a 1-hour intravenous (IV) infusion once every 2 weeks (Day 1 of each cycle) and crizotinib 250 mg (starting dose) orally twice a day (BID) on a continuous daily dosing schedule. 10 None 5 12 12 12 View
Group B: Avelumab + Lorlatinib Participants with locally advanced or metastatic ALK-positive NSCLC received avelumab 10 mg/kg as a 1-hour IV infusion once every 2 weeks (Day 1 of each cycle) and lorlatinib 100 mg (starting dose) orally once a day (QD) on a continuous daily dosing schedule. 15 None 21 31 28 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25.0 View
Cardiac tamponade NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v25.0 View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v25.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Disease progression NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Immune-mediated hepatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v25.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Clostridium difficile infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Postoperative wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Femoral neck fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25.0 View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25.0 View
Road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Central nervous system vasculitis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Cerebral haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v25.0 View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v25.0 View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v25.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v25.0 View
Superior vena cava occlusion NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v25.0 View
Sudden death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Non-small cell lung cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v25.0 View
Tongue neoplasm malignant stage unspecified NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25.0 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v25.0 View
Atrioventricular block first degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v25.0 View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v25.0 View
Tinnitus NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA v25.0 View
Hypothermia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Localised oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Swelling face NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Oesophageal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Immune-mediated hepatitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v25.0 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Lower respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Tooth abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v25.0 View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25.0 View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Amylase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Blood alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Blood cholesterol increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Electrocardiogram QT prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Hypophonesis NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Acidosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Hypercholesterolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Hypertriglyceridaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v25.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.0 View
Groin pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.0 View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.0 View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.0 View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v25.0 View
Carpal tunnel syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Hemiparesis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v25.0 View
Hallucination NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v25.0 View
Hallucination, visual NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v25.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v25.0 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v25.0 View
Nephropathy toxic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v25.0 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v25.0 View
Vaginal discharge NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v25.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Lung opacity NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v25.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Skin hypertrophy NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Proctalgia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v25.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v25.0 View
Blood triglycerides increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v25.0 View
Hyperaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v25.0 View
Restlessness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v25.0 View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v25.0 View
Hypothyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA v25.0 View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v25.0 View
Keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v25.0 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v25.0 View