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 @ 9:23 PM
Ignite Modification Date: 2025-12-25 @ 7:09 PM
NCT ID: NCT00321932
Description: Adverse reactions to Zometa® (zoledronic acid for injection) are usually mild and transient and similar to those reported for other bisphosphonates. Therefore, only serious events were collected.
Frequency Threshold: 5
Time Frame: Serious adverse events are collected from first dose of study medication through 30 days of the last dose of treatment. Any death that occured within one year of first treatment is also included.
Study: NCT00321932
Study Brief: Zoledronic Acid in Preventing Osteoporosis in Patients Undergoing Donor Stem Cell Transplant
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm I (Standard of Care) Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months. None None 8 29 0 0 View
Arm II (Treatment With Zometa) Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation. None None 21 32 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Graft-versus-host disease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Idiopathic pulmonary syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Infection with unknown absolute neutrophil count SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
New Malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (3.0) View
Nosebleed SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Pseudomonas sepsis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Other Events(If Any):