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: 2025-12-25 @ 3:54 AM
Ignite Modification Date: 2025-12-26 @ 2:44 AM
NCT ID: NCT02910102
Description: None
Frequency Threshold: 5
Time Frame: Screening through post-treatment (Up to 16 Weeks)
Study: NCT02910102
Study Brief: Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RVT-101 35 mg Subjects who dosed with RVT-101 in both sequences (AB and BA) are included 0 None 0 38 0 38 View
Placebo Subjects who dosed with Placebo in both sequences (AB and BA) are included 0 None 0 38 0 38 View
Screening Period Participants screened (0-4 weeks) prior to entering to the first dose of single-blind study medication (ie, prior to the Run-In period) 0 None 0 68 0 68 View
Run-In Period Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet (for 2 weeks) 0 None 0 40 0 40 View
RVT-101 Post-Treatment Subjects reported adverse events after completing the treatment period. The Post-Treatment period - defined as up to 17 days post-last-dose 0 None 0 38 0 38 View
Placebo Post-Treatment Subjects reported adverse events after completing the treatment period. The Post-Treatment period - defined as up to 17 days post-last-dose 0 None 0 38 0 38 View
Serious Events(If Any):
Other Events(If Any):