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 @ 10:51 PM
Ignite Modification Date: 2025-12-25 @ 8:20 PM
NCT ID: NCT00881569
Description: A treatment-emergent adverse event (TEAEs) was defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.
Frequency Threshold: 0
Time Frame: Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months.
Study: NCT00881569
Study Brief: Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CS-7017 0.75 mg BID Participant who received oral CS-7017 0.75 mg twice daily (BID). 0 None 0 1 1 1 View
CS-7017 0.50 mg BID Participant who received oral CS-7017 0.50 mg twice daily (BID). 0 None 0 1 1 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypercholesterolemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Hypertriglceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Regurgitation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Tongue paralysis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View