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 @ 10:48 PM
Ignite Modification Date: 2025-12-25 @ 8:17 PM
NCT ID: NCT03155269
Description: None
Frequency Threshold: 1
Time Frame: 180 days +/- 7
Study: NCT03155269
Study Brief: To Investigate the Impact of a Nutritional Supplement on Bone Turnover Markers in Indian Healthy Premenopausal Women (25- 45 Years) After 6 Months of Intervention
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Product Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. 0 None 0 57 19 57 View
Reference Product Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. 0 None 0 57 19 57 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood PTH increased SYSTEMATIC_ASSESSMENT Investigations None View
Urine calcium/ creatinine ratio increased SYSTEMATIC_ASSESSMENT Investigations None View
Vitamin-D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Vitamin-B 12 deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hunger SYSTEMATIC_ASSESSMENT General disorders None View