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: 2025-12-24 @ 11:35 PM
Ignite Modification Date: 2025-12-25 @ 9:24 PM
NCT ID: NCT03237156
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: TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
Study: NCT03237156
Study Brief: Phase 1 TAK-906 Single and Multiple Ascending Dose Study in Japanese Healthy Male Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohorts 1-3: Placebo TAK-906 placebo-matching capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 placebo-matching capsules, orally twice daily from Day 3 to Day 7 in Multiple Dose Period. 0 None 0 6 1 6 View
Cohort 1: TAK-906 50 mg TAK-906 50 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 50 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period. 0 None 0 6 0 6 View
Cohort 2: TAK-906 100 mg TAK-906 100 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 100 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period. 0 None 0 6 2 6 View
Cohort 3: TAK-906 10 mg TAK-906 10 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 10 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period. 0 None 0 6 1 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.0) View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.0) View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.0) View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (20.0) View