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 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:22 AM
NCT ID: NCT03228433
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 the study drug up to Day 184
Study: NCT03228433
Study Brief: A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy 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 1-5: Placebo TAK-418 placebo-matching, capsule, orally, once on Day 1. 0 None 0 10 4 10 View
Cohort 3A: TAK-418 30 mg Fasted TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1. 0 None 0 6 3 6 View
Cohort 3B: TAK-418 30 mg Fed TAK-418 30 mg, capsule, in fed state, orally, once on Day 1. 0 None 0 5 1 5 View
Cohort 4: TAK-418 40 mg TAK-418 40 mg, capsule, orally, once on Day 1. 0 None 0 6 3 6 View
Cohort 5: TAK-418 60 mg TAK-418 60 mg, capsule, orally, once on Day 1. 0 None 0 6 3 6 View
Cohort 1: TAK-418 5 mg TAK-418 5 mg, capsule, orally, once on Day 1. 0 None 0 6 2 6 View
Cohort 2: TAK-418 15 mg TAK-418 15 mg, capsule, orally, once on Day 1. 0 None 0 6 2 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (21.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Testicular pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (21.0) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (21.0) View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (21.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View