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 @ 11:10 PM
Ignite Modification Date: 2025-12-25 @ 8:44 PM
NCT ID: NCT00639769
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00639769
Study Brief: Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic 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
Therapeutic Intervention Cisplatin, Starting dose 30 mg/m2 Dose level -1 20 mg/m2; Irinotecan, Starting Dose 50 mg/m2, Dose level -1 40 mg/m2 None None 27 40 0 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal distention None Gastrointestinal disorders None View
Abdominal pain None Gastrointestinal disorders None View
Anorexia None Metabolism and nutrition disorders None View
Aspiration pneumonia None Respiratory, thoracic and mediastinal disorders None View
Chills None General disorders None View
Cholelithiasis None Hepatobiliary disorders None View
Creatinine increased None Investigations None View
Dehydration None Metabolism and nutrition disorders None View
Depressed level of consciouness None Nervous system disorders None View
Diarrhea None Gastrointestinal disorders None View
Dysphagia - esophageal (related to radiation) None Gastrointestinal disorders None View
Dysphagia, esophagitis, odynophagai None Gastrointestinal disorders None View
Facial cellulitis None Infections and infestations None View
Fatigue None General disorders None View
Febrile neutropenia None Blood and lymphatic system disorders None View
Fever None General disorders None View
Headache None Nervous system disorders None View
Hemoglobin decreased None Investigations None View
Hyponatremia None Metabolism and nutrition disorders None View
Hypotension None Vascular disorders None View
Illeus None Gastrointestinal disorders None View
Infected gastrocutaneous fistula None Gastrointestinal disorders None View
Leukocytes (WBC 1.3) None Investigations None View
Muscle weakness None Musculoskeletal and connective tissue disorders None View
Nausea None Gastrointestinal disorders None View
Neutrophil count decreased None Investigations None View
Platelet count decreased None Investigations None View
Pneumonitis None Respiratory, thoracic and mediastinal disorders None View
Post-nasal drip None General disorders None View
Right shoulder pain None Musculoskeletal and connective tissue disorders None View
Small bowel obstruction None Gastrointestinal disorders None View
Subacute fx of L1 vertebral body None Musculoskeletal and connective tissue disorders None View
Thromboembolism None Vascular disorders None View
Urosepsis None Infections and infestations None View
Vomiting None Gastrointestinal disorders None View
Weakness None General disorders None View
White blood cell decrease None Investigations None View
Other Events(If Any):