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 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT02436759
Description: Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Frequency Threshold: 2
Time Frame: Duration of treatment is 6 weeks (42 Days)
Study: NCT02436759
Study Brief: Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RVL-1201 RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning 0 None 1 94 20 94 View
Vehicle Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning 0 None 0 46 15 46 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hyperparathyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders Dictionary Version M View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Stress NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Punctate keratitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Ocular hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Conjunctival haemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Diabetic retinopathy NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Erythema of eyelid NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Eye pruritus NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Foreign body sensation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Iritis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Vitreous detachment NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Instillation site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Vital dye staining cornea present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Atrial fibrilation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.0 View