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 @ 1:18 AM
Ignite Modification Date: 2025-12-25 @ 11:26 PM
NCT ID: NCT02303093
Description: None
Frequency Threshold: 1
Time Frame: Approximately 12 months, observational study
Study: NCT02303093
Study Brief: Non-Interventional Study on the Tolerability and Efficacy of IVIG
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Octagam 10% and Panzyga, While Under Panzyga Octagam 10% and Panzyga, while under Panzyga 0 None 0 11 9 11 View
Octagam 5% Octagam 5% 1 None 3 139 13 139 View
Octagam 10% Octagam 10% 0 None 1 183 37 183 View
Octagam 5% and Octagam 10%, While Under Octagam 5% Octagam 5% and Octagam 10%, while under Octagam 5% 0 None 0 11 0 11 View
Octagam 5% and Octagam 10%, While Under Octagam 10% Octagam 5% and Octagam 10%, while under Octagam 10% 0 None 0 11 1 11 View
Octagam 10% and Panzyga, While Under Octagam 10% Octagam 10% and Panzyga, while under Octagam 10% 0 None 1 11 9 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations None View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders None View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders None View
FEELING COLD SYSTEMATIC_ASSESSMENT General disorders None View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders None View
FEELING OF BODY TEMPERATURE CHANGE SYSTEMATIC_ASSESSMENT General disorders None View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders None View
DISTURBANCE IN ATTENTION SYSTEMATIC_ASSESSMENT Nervous system disorders None View
TREMOR SYSTEMATIC_ASSESSMENT Nervous system disorders None View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
HYPERHIDROSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
COLD SWEAT SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH PRURITIC SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH ERYTHEMATOUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
FLUSHING SYSTEMATIC_ASSESSMENT Vascular disorders None View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
HOT FLUSH SYSTEMATIC_ASSESSMENT Vascular disorders None View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MUSCULOSKELETAL DISCOMFORT SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
DYSPHONIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
LOWER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
BLOOD GLUCOSE INCREASED SYSTEMATIC_ASSESSMENT Investigations None View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
SLEEP DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
CYANOSIS SYSTEMATIC_ASSESSMENT Cardiac disorders None View
HYPERSENSITIVITY SYSTEMATIC_ASSESSMENT Immune system disorders None View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders None View
ABDOMINAL DISCOMFORT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PARAESTHESIA ORAL SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
URTICARIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View