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 @ 3:50 PM
Ignite Modification Date: 2025-12-25 @ 1:56 PM
NCT ID: NCT01366092
Description: Participants were evaluated for adverse events at every clinical visit during Weeks 1,2,4,6,8.10,12,16 and every 4 weeks on extended duration therapy. Only serious adverse events and other adverse events that occurred during the 16-week study period are recorded here. Per protocol, only AEs Grade 3 or higher were recorded.
Frequency Threshold: 0
Time Frame: From first dose of study drug at Week 1 until Week 16 visit.
Study: NCT01366092
Study Brief: Daily IL-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Interleukin-2 Interleukin-2: Daily subcutaneous IL-2 (1 x 10\^6 IU/m\^2/day) for self-administration for 12 weeks followed by 4-week hiatus None None 4 35 10 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Streptococcus viridans infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (4.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (4.0) View
Peripheral Motor Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (4.0) View
Thromoembolic Event SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Platelet count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View