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 @ 1:04 AM
Ignite Modification Date: 2025-12-25 @ 11:17 PM
NCT ID: NCT00824993
Description: None
Frequency Threshold: 1
Time Frame: Baseline to 12 months
Study: NCT00824993
Study Brief: Prevention of Osteoporosis in Bone Marrow Transplantation (BMT) Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ibandronate One 3 mg dose of ibandronate i.v. over 15 to 30 seconds at entry, 3, 6 and 9 months after allo-SCT, and elemental calcium 500 mg and vitamin D 800 IU per day for 12 months 1 None 0 39 21 39 View
Control Elemental calcium 500 mg and vitamin D 800 IU per day for 12 months 3 None 0 39 24 39 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infection - Other (Bacteremia) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
GI GVHD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View