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 @ 2:38 AM
Ignite Modification Date: 2025-12-26 @ 1:16 AM
NCT ID: NCT00668434
Description: None
Frequency Threshold: 0
Time Frame: Entire study period, up to 52 weeks
Study: NCT00668434
Study Brief: Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prednisone Participants will receive a 15-day tapering course of prednisone capsules. Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days. None None 3 181 143 181 View
Placebo Participants will receive a 15-day course of placebo capsules. Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine. None None 2 88 63 88 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Partial nephrectomy SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Deep venous thrombosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Upper GI bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Appendectomy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiovascular problem SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dermatologic problem SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ear or eye disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Gastrointestinal problem SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Genitourinary problem SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Neurologic problem SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pulmonary problem SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Kidney problem SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View