Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:46 PM
NCT ID: NCT00183794
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00183794
Study Brief: Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gemcitabine and Docetaxel Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks. None None 12 20 13 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Alkaline Phosphatase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Febrile Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
White Blood Cell Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Wound Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peripheral Motor Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Creatinine Increased SYSTEMATIC_ASSESSMENT Investigations None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
White Blood Cell Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Peripheral Sensory Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pin NON_SYSTEMATIC_ASSESSMENT General disorders None View
Rash/Acneiform NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Platelet Count Decreased SYSTEMATIC_ASSESSMENT Investigations None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Blood Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline Phosphatase SYSTEMATIC_ASSESSMENT Investigations None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Localized Edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nail Discoloration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bruising NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Purpura NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weight Gain NON_SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate Aminotrasferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine Aminotransferase Increased SYSTEMATIC_ASSESSMENT Investigations None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Mucosits Oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Watering Eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hot Flashes NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Skin Disorder - Other (specify: skin tear) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View