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 @ 12:16 AM
Ignite Modification Date: 2025-12-25 @ 10:19 PM
NCT ID: NCT00945958
Description: Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.
Frequency Threshold: 0
Time Frame: 24 weeks
Study: NCT00945958
Study Brief: Evaluation of Safety of SPARC0913 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
SPARC0913 From the start of the study through Week 24 (Visit 7, End of Evaluations) adverse events were evaluated None None 5 161 140 161 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Peripheral vascular disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Acute tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Epididymitis orchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Carotid stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncopal episode SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza, Sinusitis, Conjunctivitis viral, Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Dizziness,Visual field defect SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Edema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Madarosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Any PT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
any PT SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Eye pain, ocular hyperemia, growh of eyelashes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View