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 @ 9:09 PM
Ignite Modification Date: 2025-12-25 @ 6:59 PM
NCT ID: NCT00683904
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00683904
Study Brief: Ixabepilone in Combination With Carboplatin in Patients With 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
Ixabepilone, 32 mg/m2 + Carboplatin 5 mg/Min/mL Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 5 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle. None None 1 6 6 6 View
Ixabepilone, 32 mg/m2 + Carboplatin 6 mg/Min/mL Ixabepilone, 32 mg/m\^2, administered as 3-hour infusion, plus carboplatin, 6 mg/min/mL, infused 30 minutes after completion of carboplatin infusion and over 30 minutes on Day 1 of each 21-day cycle. None None 0 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
SUPERIOR VENA CAVAL OCCLUSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthenopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.1 View
Protein urine SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Glucose urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood sodium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood albumin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Protein total decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Superior vena caval occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Glycosuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.1 View