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 @ 5:05 AM
Ignite Modification Date: 2025-12-26 @ 4:08 AM
NCT ID: NCT02554318
Description: The definition of adverse event and/or serious adverse event, used to collect adverse event information, are the same from the clinicaltrials.gov definitions. Observation for adverse event was done three times a week since the food should be delivered regularly and regular notes taken on a log book.
Frequency Threshold: 0.013
Time Frame: The intervention period was 2 months for each participant who is eligible for the study. All participants were assessed at month zero (baseline) and month two (end line). The recruitment method was not a one-time event but a referral from physicians. Since eligible participants were not always available every day at the clinics thus the adverse data collection period for all participants was 1 year and 3 months.
Study: NCT02554318
Study Brief: Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention TB standard therapy with fixed dose combination : once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol, Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets and 166.5 grams cooked fermented soybean (tempeh) daily for two months Rifampicin Isoniazid Pyrazinamide Ethambutol Fermented soybean 0 None 0 75 1 75 View
Control TB standard therapy with fixed dose combination : once per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol, Patients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets Rifampicin Isoniazid Pyrazinamide Ethambutol 0 None 0 72 0 72 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Vomiting View