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 @ 2:35 PM
Ignite Modification Date: 2025-12-25 @ 1:07 PM
NCT ID: NCT02465359
Description: Definitions do not differ to ClinicalTrials.gov adverse event definitions.
Frequency Threshold: 5
Time Frame: 24 Weeks
Study: NCT02465359
Study Brief: Subcutaneous Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Immune Globulin Subcutaneous (Human) lmmune Globulin Subcutaneous(Human) 20% Liquid (Hizentra) will be given weekly Immune Globulin Subcutaneous (Human): Patients who have CIDP and are on IVIG will be allowed in the study to try subcutaneous immune Globulin (SCIG) as part of an open label study. 0 None 0 15 13 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain at infusion site NON_SYSTEMATIC_ASSESSMENT General disorders None View
Transient swelling at site of infusion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Redness at site of infusion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Itching at site of infusion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Numbness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bruising at site of infusion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Increased Exhaustion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hedache/Migrane NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tingling sensation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Burning sensation at site of infusion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain in the extremities NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fell/fainted NON_SYSTEMATIC_ASSESSMENT General disorders None View
Generalized itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Backache NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Twitching NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CIDP exacerbation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Heavy legs NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bleeding at site of infusion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Eyes burning NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Severe hip osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Induration at site of infusion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Local heat at site of infusion NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Increased weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Stabbing Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Shingles NON_SYSTEMATIC_ASSESSMENT General disorders None View