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 @ 11:44 PM
Ignite Modification Date: 2025-12-25 @ 9:36 PM
NCT ID: NCT01240551
Description: Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.
Frequency Threshold: 0
Time Frame: Date treatment consent signed to date off study, approximately 52.5 months.
Study: NCT01240551
Study Brief: F-18 Sodium Fluoride in Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mets Via NaF-18 PET/CT F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period. 0 None 1 30 1 30 View
No-Mets Via NaF-18 PET/CT F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period. 0 None 0 30 1 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Renal calculi SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (4.0) View
Pain SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View