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 @ 10:07 PM
Ignite Modification Date: 2025-12-25 @ 7:43 PM
NCT ID: NCT07214935
Description: None
Frequency Threshold: 0
Time Frame: Up to 3 months
Study: NCT07214935
Study Brief: A TQT Study of Effect of M2951 on Cardiac Repolarization
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received single oral solution of placebo in treatment period 1, 2, 3 or 4 under fasted condition 0 None 0 32 8 32 View
400 mg Moxifloxacin Participants received single oral dose of Moxifloxacin 400mg in treatment period 1, 2, 3 or 4under fasted condition 0 None 0 32 5 32 View
45 mg Evobrutinib Participants received single oral dose of Evobrutinib 45 milligram (mg) in treatment period 1, 2, 3 or 4 under fasted condition 0 None 0 31 8 31 View
225 mg Evobrutinib Participants received single oral dose of Evobrutinib 225 mg in treatment period 1, 2, 3 or 4 under fasted condition 0 None 0 32 5 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations meddra 25.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations meddra 25.1 View
Periorbital haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications meddra 25.1 View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations meddra 25.1 View
Lipase increased NON_SYSTEMATIC_ASSESSMENT Investigations meddra 25.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra 25.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra 25.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra 25.1 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders meddra 25.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders meddra 25.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders meddra 25.1 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders meddra 25.1 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders meddra 25.1 View
Atrioventricular block second degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders meddra 25.1 View
Ventricular extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders meddra 25.1 View
Ventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders meddra 25.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders meddra 25.1 View