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 @ 3:06 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT00720759
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected from trial entry through 3 months following treatment completion.
Study: NCT00720759
Study Brief: Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1 D-cycloserine + distributed treatment D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session None None 0 6 0 6 View
Arm 2 D-cycloserine + condensed treatment D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session None None 0 6 0 6 View
Arm 3 Placebo + distributed treatment Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session None None 1 6 1 6 View
Arm 4 Placebo + condensed treatment Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session None None 0 6 1 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Recurrent stroke SYSTEMATIC_ASSESSMENT Nervous system disorders Standard to our IRB View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders Standard to our IRB View
skin tear SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Standard to our IRB View