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 @ 4:56 AM
Ignite Modification Date: 2025-12-26 @ 3:56 AM
NCT ID: NCT04139018
Description: None
Frequency Threshold: 0
Time Frame: Adverse events collected throughout the whole duration of the study and assessed multiple times throughout a participant's 8 weeks of intervention.
Study: NCT04139018
Study Brief: Timolol Gel for Epistaxis in Hereditary Hemorrhagic Telangiectasia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Timolol Gel Arm Participants in the timolol gel arm (active medication arm) will receive timolol nasal gel 0.1% with 0.5 mL applied to each nostril twice daily via a syringe that will amount to a 2 mg total daily dose. Timolol Gel: Timolol nasal gel 0.1% will be prepared with a poloxamer gel (combination of poloxamer 188 and 407; pH adjusted to 4.5-6.5) and 0.5 ml applied to each nostril twice daily. The total daily dose would amount to 2 mg. 0 None 0 14 7 14 View
Placebo Gel Arm Participants in the placebo gel arm will receive the gel itself with no active medication. Placebo Gel: Placebo gel is prepared with poloxamers and no active ingredients. 0 None 0 13 3 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Vascular disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Bad taste of medication SYSTEMATIC_ASSESSMENT General disorders None View
Sore throat SYSTEMATIC_ASSESSMENT General disorders None View
Irritation upon applying gel SYSTEMATIC_ASSESSMENT General disorders None View