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 @ 4:58 AM
Ignite Modification Date: 2025-12-26 @ 3:58 AM
NCT ID: NCT02459418
Description: A TEAE was defined as any adverse event that began or worsened following first dose administration. Adverse events (AEs) occurring between treatments were attributed to the last treatment received. Subjects were asked about AEs at each contact with the site (visits and telephone calls).
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse event (TEAEs) were reported from study day 1 to study day 35.
Study: NCT02459418
Study Brief: Comparative Pharmacokinetics of AFOLIA and US Gonal-f® RFF Redi-ject After Single Subcutaneous Application
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AFOLIA This analysis set contained all subjects who received one dose of AFOLIA (225 IU). 0 None 0 36 21 36 View
Gonal-f® RFF This analysis set contained all subjects who received one dose of Gonal-f® RFF (225 IU). 0 None 0 34 22 34 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (18.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.1) View
Catheter site related reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.1) View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.1) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (18.1) View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.1) View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.1) View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (18.1) View