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 @ 1:43 AM
Ignite Modification Date: 2025-12-26 @ 12:01 AM
NCT ID: NCT04478994
Description: None
Frequency Threshold: 0
Time Frame: From enrollment (all-cause mortality) or first dose of trial drug on Day 1 (adverse events) until 3 weeks (21 days) after last dose of trial drug, up to Week 48.
Study: NCT04478994
Study Brief: A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TEPEZZA 20 mg/kg Participants receive 8 infusions of TEPEZZA every 3 weeks (q3W) for a total of 21 weeks: TEPEZZA 10 mg/kg administered on Day 1 and TEPEZZA 20 mg/kg administered q3W for the remaining 7 infusions. 0 None 0 1 0 1 View
Placebo Participants receive 8 infusions of placebo q3W for a total of 21 weeks. 0 None 1 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chronic lymphocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View