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: 2025-12-24 @ 11:45 PM
Ignite Modification Date: 2025-12-25 @ 9:38 PM
NCT ID: NCT02939651
Description: None
Frequency Threshold: 0
Time Frame: 30 months
Study: NCT02939651
Study Brief: A Study of Pembrolizumab in Patients With Neuroendocrine Tumors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pembrolizumab Monotherapy with PD-1 antibody pembrolizumab Pembrolizumab: Pembrolizumab given intravenously at a fixed dose of 200mg every 3 weeks 15 None 5 21 21 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholangitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Polymyaglia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Elevated ALT NON_SYSTEMATIC_ASSESSMENT Investigations None View
Elevated ALK NON_SYSTEMATIC_ASSESSMENT Investigations None View
Upper GI bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorexia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Edema limbs NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Alkaline phosphatase increased NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal disorders NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders and administration site conditions NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rectal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Skin and subcutaneous tissue disorders NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT General disorders None View