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 @ 10:58 PM
Ignite Modification Date: 2025-12-25 @ 8:27 PM
NCT ID: NCT06840769
Description: None
Frequency Threshold: 0
Time Frame: The reporting period for adverse events is the period starting from the time of informed consent signature and lasting until the final visit. Adverse events were collected for each participant for the whole period of the study (i.e., a maximum of 28 days).
Study: NCT06840769
Study Brief: A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study Part A - Cohort 1 - Akynzeo 10 subjects were included in the study as planned and received the injection of Akynzeo solution in 30 min. 0 None 0 10 5 10 View
Study Part A - Cohort 1 - Fosnetupitant 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 30 min. 0 None 0 10 3 10 View
Study Part A - Cohort 2 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 15 min. 0 None 0 10 2 10 View
Study Part A - Cohort 3 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 5 min. 0 None 0 10 1 10 View
Study Part A - Cohort 4 10 subjects were included in the study as planned and received the injection of Fosnetupitant 235 mg solution in 2 min. 0 None 0 10 4 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Infusion site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Injection site discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
AST increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View