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 @ 6:29 PM
Ignite Modification Date: 2025-12-25 @ 3:59 PM
NCT ID: NCT02666768
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected from day 1 to end of study or participant withdrawal, up to year 1.
Study: NCT02666768
Study Brief: ACTIMMUNE in Intermediate Osteopetrosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gamma Interferon-1b Gamma interferon-1b 100 mcg SC 3 times weekly for 12 months Interferon gamma-1b: gamma interferon-1b dose escalation over first 4 weeks of study to 100 mcg SC 3 times weekly 0 None 0 5 5 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Flu-like reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Injection site reactions SYSTEMATIC_ASSESSMENT General disorders None View
Sinusitis/sinus pain/sinus congestion NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bone pain - generalized NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View