Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:32 PM
Ignite Modification Date: 2025-12-25 @ 3:05 PM
NCT ID: NCT01420068
Description: None
Frequency Threshold: 0
Time Frame: This study only collected the occurrence of Serious Adverse Events (SAEs) occurring within the first 30 days after the participant had completed the first extension study. SAEs experienced after this 30 day period were reported to Novartis/Noden only if the investigator suspected a causal relationship to the study drug. Every SAE, within the above timeframe was to be reported to Novartis/Noden within 24 hours of learning of its occurrence.
Study: NCT01420068
Study Brief: 52-104 Week Off-therapy Second Extension to Study CSPP100A2365
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Enalapril No study treatment (aliskiren or enalapril) was administered in this off-therapy non-interventional second extension study. The arm/group in this second extension study refers to the actual treatment arm/group assigned at the end of the first extension study (Study CSPP100A2365E1: ClinicalTrials.gov Identifier: NCT01151410). During Study CSPP100A2365E1, participants were to receive one of the following doses of enalapril based on their weight: low weight (≥20 to \<50 kg) participants - starting dose 2.5 mg with optional titration to 5 and then 10 mg; mid weight (≥50 to \<80 kg) participants - starting dose 5 mg with optional titration to 10 and then 20 mg; high weight (≥80 to ≤150 kg) participants - starting dose 10 mg with optional titration to 20 and then 40 mg. 0 None 1 51 0 51 View
Aliskiren No study treatment (aliskiren or enalapril) was administered in this off-therapy non-interventional second extension study. The arm/group in this second extension study refers to the actual treatment arm/group assigned at the end of the first extension study (Study CSPP100A2365E1: ClinicalTrials.gov Identifier: NCT01151410). During Study CSPP100A2365E1, participants were to receive one of the following doses of aliskiren based on their weight: low weight (≥20 to \<50 kg) participants - starting dose 37.5 mg with optional titration to 75 and then 150 mg; mid weight (≥50 to \<80 kg) participants - starting dose 75 mg with optional titration to 150 and then 300 mg; high weight (≥80 to ≤150 kg) participants - starting dose 150 mg with optional titration to 300 and then 600 mg. 0 None 0 55 0 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Phimosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Other Events(If Any):