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 @ 2:51 AM
Ignite Modification Date: 2025-12-26 @ 1:32 AM
NCT ID: NCT03939533
Description: None
Frequency Threshold: 5
Time Frame: Through study complete, up to 28 weeks
Study: NCT03939533
Study Brief: Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Increased Infusion Rate Cohort - Cohort 2 Increased infusion rate - patients will receive CUTAQUIG weekly and increase infusion rates every 4 weeks CUTAQUIG: Human normal immunoglobulin 0 None 1 15 12 15 View
Increased Volume Cohort - Cohort 1 Increased volume at each infusion site - patients will receive CUTAQUIG weekly and increase infusion volumes every 4 weeks CUTAQUIG: Human normal immunoglobulin 0 None 1 15 13 15 View
Every Other Week Dosing Cohort - Cohort 3 Every other week dosing - patients will receive CUTAQUIG every other week at the equivalent of twice their body-weight dependent \[mg/kg\] weekly dose CUTAQUIG: Human normal immunoglobulin 0 None 1 34 30 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (19.0) View
Rheumatoid Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (19.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Infusion Site Erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Infusion Site Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Infusion Site Pruritis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Acute Sinitus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Ear Infection NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (19.0) View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Heachache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (19.0) View