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 @ 1:27 AM
Ignite Modification Date: 2025-12-25 @ 11:39 PM
NCT ID: NCT02879994
Description: Period of active patient enrollment
Frequency Threshold: 0
Time Frame: Up to 14 months
Study: NCT02879994
Study Brief: Pembrolizumab in Treating Patients With EGFR Mutant, Tyrosine Kinase Inhibitor Naive Advanced Non-Small Cell 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
Treatment (Pembrolizumab) Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV 2 None 6 11 6 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Hypotension NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Elevated alanine aminotransferase NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (4.0) View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (4.0) View
Adrenal insufficiency NON_SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (4.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Flu-like symptoms NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Thyroid-stimulating hormone decreased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View