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 @ 12:56 AM
Ignite Modification Date: 2025-12-25 @ 11:10 PM
NCT ID: NCT03298867
Description: None
Frequency Threshold: 5
Time Frame: From first dose of study drug through the end of the Double-Masked Treatment Period (up to 24 weeks) plus 3 weeks.
Study: NCT03298867
Study Brief: Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Eight infusions of placebo q3W for a total of 21 weeks. 0 None 1 42 29 42 View
Teprotumumab 20 mg/kg Eight infusions of teprotumumab q3W for a total of 21 weeks. Teprotumumab 10 mg/kg administered on Day 1 and teprotumumab 20 mg/kg administered q3W for the remaining 7 infusions. 0 None 2 41 37 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Visual field defect SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Madarosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Amenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View