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 @ 4:31 PM
Ignite Modification Date: 2025-12-25 @ 2:24 PM
NCT ID: NCT02918266
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 that started after the first dose of study drug up to Day 12 in Part 1 and Day 9 of Period 1 in Part 2 (study termination) after the last dose of study drug
Study: NCT02918266
Study Brief: TAK-071 Scopolamine-Induced Cognitive Impairment Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg TAK-071 80 milligram (mg), drug in capsule (DIC), orally, on Day 1, followed by scopolamine 0.5 mg, injection, subcutaneously (SC), on Day 2. 0 None 0 6 4 6 View
Part 2: Treatment A TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine placebo-matching injection, SC, on Day 2 in each intervention period. 0 None 0 3 2 3 View
Part 2: Treatment B TAK-071 placebo-matching DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. 0 None 0 2 2 2 View
Part 2: Treatment C TAK-071 80 mg, DIC, orally, on Day 1, donepezil placebo-matching over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. 0 None 0 3 3 3 View
Part 2: Treatment D TAK-071 80 mg, DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. 0 None 0 2 2 2 View
Part 2: Treatment E TAK-071 placebo-matching DIC, orally, on Day 1, donepezil 10 mg, over-encapsulated tablet, orally along with scopolamine 0.5 mg, injection, SC, on Day 2 in each intervention period. 0 None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View