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 @ 2:17 AM
Ignite Modification Date: 2025-12-26 @ 12:46 AM
NCT ID: NCT00737360
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were summarized for all courses of study medication.
Study: NCT00737360
Study Brief: Phase II Study of TAS-106 to Treat 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
TAS-106 None None None 15 27 27 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Gastrointestinal perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Face oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Lymph node abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Hemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Salivary hypersecretion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Face oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Infusion site discolouration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Hyperbilirubinaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Muscle twitching NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Haemoptysis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Palmar-plantar erythrodysaesthesia syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Skin exfoliation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View