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: 2025-12-26 @ 10:37 AM
Ignite Modification Date: 2025-12-26 @ 10:37 AM
NCT ID: NCT01205828
Description: None
Frequency Threshold: 4
Time Frame: 6 months
Study: NCT01205828
Study Brief: ABT-888 and Temozolomide for Liver 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
Temozolomide + ABT-888 Temozolomide and ABT-888 temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months). None None 6 16 16 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
nausea, vomit NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
multiorgan failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
platelet count decrease NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
low neutrophil NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
low lymphocyte NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
nausea, vomit NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View