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 @ 10:10 PM
Ignite Modification Date: 2025-12-25 @ 7:45 PM
NCT ID: NCT02497235
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. Adverse events were summarized separately for Baseline period and TAK-935 dosing groups.
Frequency Threshold: 0
Time Frame: Baseline up to Day 28
Study: NCT02497235
Study Brief: A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TAK-935 600 mg TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of \[18F\]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later. None None 0 3 1 3 View
Baseline [18F]MNI-792 \[18F\]MNI-792 up to 370 MBq (10mCi) with a mass of up to 5 mcg, injection, intravenously, prior to Positron Emission Tomography (PET) imaging at Baseline. None None 0 11 1 11 View
TAK-935 50 mg TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of \[18F\]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose. None None 0 2 1 2 View
TAK-935 100 mg TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of \[18F\]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose. None None 0 2 1 2 View
TAK-935 200 mg TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of \[18F\]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose. None None 0 2 1 2 View
TAK-935 300 mg TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of \[18F\]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose. None None 0 2 1 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (18.0) View
Catheter site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.0) View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.0) View