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 @ 12:30 PM
Ignite Modification Date: 2025-12-25 @ 12:09 PM
NCT ID: NCT00947661
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00947661
Study Brief: Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SPARC0912 SPARC's formulation administered once daily for 12 weeks None None 3 289 3 289 View
Reference0912 Reference formulation administered once daily for 12 weeks None None 5 289 4 289 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Macular edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Colitis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rotator cuff syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Elevated blood pressure NON_SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
abdominal pain, colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations None View
Back pain, Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View