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 @ 4:52 PM
Ignite Modification Date: 2025-12-25 @ 2:35 PM
NCT ID: NCT04481750
Description: None
Frequency Threshold: 0
Time Frame: 8 days in part 1, 12 days in part 2
Study: NCT04481750
Study Brief: Study of Oral Edaravone in Healthy Adult Males
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A Single Dose MT-1186 (Part 1, Cohort S1) Healthy Japanese male subjects receive a single dose of MT-1186 60 mg solution. 0 None 0 6 0 6 View
A Single Dose MT-1186 (Part 1, Cohort S2) Healthy Japanese male subjects receive a single dose of MT-1186 120 mg suspension. 0 None 0 6 2 6 View
A Single Dose MT-1186 (Part 1, Cohort S3) Healthy Japanese male subjects receive a single dose of MT-1186 200 mg under fasted condition in period 1, and fed condition in period 2 with washout period at least 4-day. 0 None 0 6 3 6 View
A Single Dose MT-1186 (Part 1, Cohort S4) Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension with xanthan. 0 None 0 6 0 6 View
A Single Dose MT-1186 (Part 1, Cohort S5) Healthy Japanese male subjects receive a single dose of MT-1186 300 mg suspension. 0 None 0 6 1 6 View
A Single Dose MT-1186 (Part 1, Cohort S6) Healthy Japanese male subjects receive a single dose of MT-1186 30 mg suspension. 0 None 0 6 1 6 View
A Single Dose MT-1186 (Part 1, Cohort S7) Healthy Caucasian male subjects receive a single dose of MT-1186 200 mg suspension. 0 None 0 6 2 6 View
Matching Placebo (a Single Dose Cohorts) Healthy Japanese/Caucasian male subjects receive a single dose of matching placebo. 0 None 0 14 2 14 View
Multiple Doses MT-1186 (Part 2, Cohort M1) Healthy Japanese male subjects receive multiple doses of MT-1186 120 mg suspension. 0 None 0 6 2 6 View
Multiple Doses MT-1186 (Part 2, Cohort M2) Healthy Japanese male subjects receive multiple doses of MT-1186 200 mg suspension. 0 None 0 6 1 6 View
Matching Placebo (Multiple Doses Cohorts) Healthy Japanese male subjects receive multiple doses of matching placebo. 0 None 0 6 1 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21.0 View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 21.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 21.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21.0 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21.0 View
Blood urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21.0 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21.0 View
Protein urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21.0 View