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 @ 3:40 PM
Ignite Modification Date: 2025-12-25 @ 1:50 PM
NCT ID: NCT00405392
Description: Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
Frequency Threshold: 0
Time Frame: Up to 6 months
Study: NCT00405392
Study Brief: Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Risedronate 35 mg Once Weekly Participants received risedronate 35 mg tablet orally once weekly for 12 weeks either in period 1 or period 2 as per the randomization sequence. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month). The treatment was administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast). 0 None 4 334 0 0 View
Ibandronate 150 mg Once Monthly Participants received ibandronate 150 mg tablet orally once in a month for 3 months either in period 1 or period 2 as per the randomization sequence. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month). The treatment was administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast). 0 None 6 336 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intervertebral Disc Disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Varicose vein operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Uterine prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Aspergilloma SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Papillary thyroid cancer SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Other Events(If Any):