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 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:47 PM
NCT ID: NCT04155567
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: TEAEs are adverse events (AEs) that started after first dose of study drug up to Day 8
Study: NCT04155567
Study Brief: A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male 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
TAK-123 3.75 g/m^2 NaPA and NaBZ TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ as loading dose, infusion, intravenously over 90 minutes, followed by TAK-123 3.75 g/m\^2 NaPA and TAK-123 3.75 g/m\^2 NaBZ maintenance dose, infusion, intravenously over 24 hours on Day 1. 0 None 0 10 6 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (22.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (22.0) View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (22.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (22.0) View