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 @ 12:01 AM
Ignite Modification Date: 2025-12-25 @ 9:58 PM
NCT ID: NCT03110458
Description: 104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects). Treatment emergent adverse events are displayed.
Frequency Threshold: 5
Time Frame: up to end of study 28 days
Study: NCT03110458
Study Brief: Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SENS-111 200mg SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg) SENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study. 0 None 1 36 5 36 View
SENS-111 100mg SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo) SENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study. 0 None 0 36 4 36 View
Placebo Placebo: 2 placebo Oral Dispersible Tablets Placebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study. 0 None 0 32 7 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Extra dose administered SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Folate deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (Unspecified) View