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 @ 5:52 PM
Ignite Modification Date: 2025-12-25 @ 3:17 PM
NCT ID: NCT03437668
Description: Definitions consistent with clinicaltrials.gov
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT03437668
Study Brief: Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Withania Somnifera Extract (WSE) WSE 500 mg bid for 12 weeks WSE: WSE tablets 0 None 1 24 12 24 View
Placebo Tablets Placebo oral tablet bid for 12 weeks Placebo Oral Tablet: Placebo tablet 0 None 3 23 18 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID 19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Objective tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acid reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea and vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Endometritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Back injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Decrease appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Auditory hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View