Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:58 AM
Ignite Modification Date: 2025-12-25 @ 11:12 PM
NCT ID: NCT03808493
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 0
Time Frame: Treatment-emergent adverse events (TEAEs) are adverse events (AE) that started after the first dose of study drug until Day 3 in Period 2 (up to Day 13)
Study: NCT03808493
Study Brief: A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pilot BE Study 1: TAK-438 OD 20 mg TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of either Period 1 or 2. 0 None 0 24 0 24 View
Pilot BE Study 2: TAK-438 OD 20 mg TAK-438 OD 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2. 0 None 0 24 0 24 View
Pilot BE Study 1: TAK-438 20 mg TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2. 0 None 0 24 0 24 View
Pilot BE Study 2: TAK-438 20 mg TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2. 0 None 0 24 0 24 View
Serious Events(If Any):
Other Events(If Any):