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 @ 1:27 AM
Ignite Modification Date: 2025-12-25 @ 11:39 PM
NCT ID: NCT02994394
Description: Safety analysis set: all subjects that received at least 1 dose of IMP.
Frequency Threshold: 2
Time Frame: Treatment-emergent adverse events were collected during the treatment period (8 days)
Study: NCT02994394
Study Brief: A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1: 15 mg Conventional Tablet Single oral administration of 1 tolvaptan 15 mg conventional tablet with water under fasting conditions 0 None 0 41 1 41 View
Cohort 1: 15 mg OD Tablet Without Water Single oral administration of 1 tolvaptan 15 mg OD tablet without water under fasting conditions 0 None 0 41 1 41 View
Cohort 1: 15 mg OD Tablet With Water Single oral administration of 1 tolvaptan 15 mg OD tablet with water under fasting conditions 0 None 0 41 2 41 View
Cohort 2: 30 mg Conventional Tablet Single oral administration of 1 tolvaptan 30 mg conventional tablet with water under fasting conditions 0 None 0 42 1 42 View
Cohort 2: 30 mg OD Tablet Without Water Single oral administration of 1 tolvaptan 30 mg OD tablet without water under fasting conditions 0 None 0 42 0 42 View
Cohort 2: 30 mg OD Tablet With Water Single oral administration of 1 tolvaptan 30 mg OD tablet with water under fasting conditions 0 None 0 41 0 41 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Ver. 20.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Ver. 20.0 View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Ver. 20.0 View