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 @ 9:16 PM
Ignite Modification Date: 2025-12-25 @ 7:04 PM
NCT ID: NCT00075504
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00075504
Study Brief: Triapine and Gemcitabine Hydrochloride in Gallbladder 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
Stratum A Normal Liver Function Triapine, Gemcitabine Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days triapine: Given IV gemcitabine: Given IV None None 21 23 22 23 View
Stratum B Abnormal Liver Function Triapine, Gemcitabine Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days triapine: Given IV gemcitabine: Given IV None None 10 10 10 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fatigue None General disorders None View
Infection None Infections and infestations None View
Hypokalemia None Metabolism and nutrition disorders None View
Infection with normal ANC or Grade 1 or 2 Neutrophils: Blood None Infections and infestations None View
Alkaline phosphatase increased None Investigations None View
Neutrophil count decreased None Investigations None View
Anemia None Blood and lymphatic system disorders None View
Platelet count decreased None Investigations None View
Thromboembolic event None Vascular disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Abdominal pain None Gastrointestinal disorders None View
Pneumonitis None Respiratory, thoracic and mediastinal disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain None Gastrointestinal disorders None View
Platelet count decreased None Investigations None View
Hypocalcemia None Metabolism and nutrition disorders None View
Hypoalbuminemia None Metabolism and nutrition disorders None View
Lymphocyte count decreased None Investigations None View
Hemoglobin None Blood and lymphatic system disorders None View
Alkaline phosphatase increase None Investigations None View
Fatigue None General disorders None View
Hyperglycemia None Metabolism and nutrition disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View