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: 2025-12-24 @ 10:58 PM
Ignite Modification Date: 2025-12-25 @ 8:27 PM
NCT ID: NCT01519869
Description: None
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT01519869
Study Brief: Trial of Chemotherapy in Ovarian, Fallopian Tube and 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
Neoadjuvant Chemotherapy platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy neoadjuvant chemotherapy: platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy 23 None 0 28 28 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bronchial infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations None View