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 @ 3:17 PM
Ignite Modification Date: 2025-12-25 @ 1:38 PM
NCT ID: NCT00106392
Description: Serious Adverse Events possibly related to study drug were collected. The only other Adverse Events collected were those associated with study drug dose changes. Subjects who experienced an Adverse Event with the same preferred term multiple times were only counted once.
Frequency Threshold: 5
Time Frame: SAEs and AEs as defined below were collected through month 6.
Study: NCT00106392
Study Brief: A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tacrolimus Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up. None None 1 59 7 59 View
Placebo Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up. None None 0 65 5 65 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (13.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (13.0) View
Renal disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (13.0) View