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 @ 11:04 PM
Ignite Modification Date: 2025-12-25 @ 8:35 PM
NCT ID: NCT02541669
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 are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
Study: NCT02541669
Study Brief: A Single- and Multiple-Dose Study of the Pharmacokinetics of TAK-491 in Healthy Chinese 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
Open Label: TAK-491 40 mg TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment. 0 None 0 8 4 8 View
Open Label: TAK-491 80 mg TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment. 0 None 0 8 4 8 View
Double-blind: Placebo TAK-491 placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment. 0 None 0 16 6 16 View
Double-blind: TAK-491 40 mg TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment. 0 None 0 16 4 16 View
Double-blind: TAK-491 80 mg TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment. 0 None 0 16 10 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (19.0) View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Gastrointestinal viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (19.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Pharyngeal erythema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (19.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (19.0) View