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 @ 2:32 AM
Ignite Modification Date: 2025-12-26 @ 1:07 AM
NCT ID: NCT01283334
Description: None
Frequency Threshold: 0
Time Frame: Up to 25 months
Study: NCT01283334
Study Brief: A Study of Carboplatin, Cetuximab and RAD001 in Advanced Head and Neck 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
Carboplatin, Cetuximab and Everolimus Carboplatin, cetuximab and RAD001 (everolimus) Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis None None 2 20 7 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nausea and vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemoptysis and death NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Aspiration pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Mucositis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anaphylaxis NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View