Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:52 AM
Ignite Modification Date: 2025-12-26 @ 2:41 AM
NCT ID: NCT03411902
Description: None
Frequency Threshold: 0
Time Frame: baseline through 12 months
Study: NCT03411902
Study Brief: Weight Loss With Risedronate for Bone Health
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 Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy. 0 None 0 13 3 13 View
Risedronate Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy. 0 None 1 11 4 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
thyroid cancer SYSTEMATIC_ASSESSMENT Endocrine disorders None View
melanoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
gastroesophageal reflux disease exacerbation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
broken ankle SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Broken humerus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View