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 @ 9:21 PM
Ignite Modification Date: 2025-12-25 @ 7:08 PM
NCT ID: NCT01860404
Description: None
Frequency Threshold: 0
Time Frame: 21 days (duration of study period)
Study: NCT01860404
Study Brief: BCAA Supplementation for Concussion
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo will be administered orally twice daily for 21 days Placebo solution: The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution. 0 None 0 8 3 8 View
Branched Chain Amino Acids (7.5g BID) 7.5 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. 0 None 0 8 3 8 View
Branched Chain Amino Acids (15g BID) 15 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. 0 None 0 9 1 9 View
Branched Chain Amino Acids (22.5g BID) 22.5 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. 0 None 0 9 0 9 View
Branched Chain Amino Acids (27g BID) 27 grams of BCAAs will be administered twice-daily for 21 days Branched Chain Amino Acids: The three BCAAs will be combined together and dissolved in a flavored solution. 0 None 0 8 1 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild (not interfering with daily life) or Moderate (limitation to daily activity) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View