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 @ 10:07 PM
Ignite Modification Date: 2025-12-25 @ 7:43 PM
NCT ID: NCT01793935
Description: 34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes
Frequency Threshold: 5
Time Frame: Adverse Events were evaluated during the study period (12 weeks)
Study: NCT01793935
Study Brief: Withania Somnifera: an Immunomodulator and Anti-inflammatory Agent for 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
Sensoril® Sensoril® is a proprietary extract of Withania Somnifera Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera 0 None 0 33 24 33 View
Placebo Placebo Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules. 0 None 0 33 20 33 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
loose stools/diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dyspepsia (heartburn) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
hyperactive SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
worsening of psychiatric symptoms SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
fatigue/lathargy SYSTEMATIC_ASSESSMENT General disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
weight gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View