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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:24 AM
NCT ID: NCT01007994
Description: None
Frequency Threshold: 0
Time Frame: 30 days after treatment duration of 6 months
Study: NCT01007994
Study Brief: Reduction of Night-time Blood Pressure in Pediatric Renal Transplant Recipients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
New Medication A new anti-hypertensive medication (enalapril, propranolol or isradipine) will be added at 8pm. New Medication: Enalapril, Isradipine, Propranolol: Enalapril will be added in the evening at 8 pm. If the subject is already on an ACEI or there is a contraindication to starting an ACEI the subject will be started on isradipine instead. If the subject is already on an ACEI and calcium channel blocker at baseline, propranolol will then be the new medication added. Dosing will be as follows: ACEI: Enalapril \< 40 kg starting dose 2.5 mg titrate to 5 mg \> 40 kg starting dose 5 mg titrate to 10mg Calcium Channel Blocker: Isradipine \< 40 kg 2.5 mg \> 40 kg starting dose 2.5 mg titrate to 5 mg Beta Blocker: Propranolol \<40 kg starting dose 10 mg titrate to 20 mg \>40 kg starting dose 20 mg titrate to 40 mg 0 None 0 17 1 17 View
Control Subjects in the control group will continue to take their medications as usual. 0 None 0 16 0 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View