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 @ 2:14 AM
Ignite Modification Date: 2025-12-26 @ 12:43 AM
NCT ID: NCT03373760
Description: CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for Serious Adverse Event (SAE) reporting. 58 participants were assessed for AEs: 28 in the primary PD-L1 resistance cohort and 30 in the acquired PD-L1 resistance cohort.
Frequency Threshold: 5
Time Frame: Duration of treatment and follow-up until death or 3 years post registration
Study: NCT03373760
Study Brief: Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MEDI4736 + Tremelimumab Participants receive tremelimumab and durvalumab on day 1 of each 28-day cycle for four cycles. Starting at cycle 5, participants receive durvalumab on day 1 of each cycle until disease progression or unacceptable toxicity. Tremelimumab: Given IV Durvalumab: Given IV 47 None 36 58 58 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neoplasms benign, malignant and unspecified - Other SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bronchopulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Resp, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bullous dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin and subcutaneous tissue disorders - Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophageal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Death NOS SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Electrocardiogram QT corrected interval prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Serum amylase increased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Endocrine disorders-Other SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Bronchial infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infections and infestations-Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Investigations-Other SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Resp, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View