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 @ 3:46 AM
Ignite Modification Date: 2025-12-26 @ 2:32 AM
NCT ID: NCT02370602
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: 5
Time Frame: First dose of study drug to 30 days after last dose of study drug (up to 46 days)
Study: NCT02370602
Study Brief: An [^11C]T-773 Positron Emission Tomography (PET) Study to Determine Phosphodiesterase10A Occupancy by TAK-063
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
[^11C]T-773 \[\^11C\]T-773 \<8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only. None None 0 13 5 13 View
TAK-063 TAK-063 3 to 1000 mg, tablets, orally, once, on Day 1. None None 0 12 9 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haematoma None Vascular disorders MedDRA 16.0 View
Anxiety None Psychiatric disorders MedDRA 16.0 View
Headache None Nervous system disorders MedDRA 16.0 View
Infusion site pain None General disorders MedDRA 16.0 View
Nausea None Gastrointestinal disorders MedDRA 16.0 View
Tremor None Nervous system disorders MedDRA 16.0 View
Catheter site pain None General disorders MedDRA 16.0 View
Chest pain None General disorders MedDRA 16.0 View
Claustrophobia None Psychiatric disorders MedDRA 16.0 View
Dizziness None Nervous system disorders MedDRA 16.0 View
Fatigue None General disorders MedDRA 16.0 View
Nasopharyngitis None Infections and infestations MedDRA 16.0 View
Infusion site erythema None General disorders MedDRA 16.0 View