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 @ 3:44 PM
Ignite Modification Date: 2025-12-25 @ 1:52 PM
NCT ID: NCT03824392
Description: The Safety Set included all participants who received any amount of study drug and were based on the actual treatment received, if this differs from that to which the participant was randomized.
Frequency Threshold: 0
Time Frame: Baseline up to Week 24
Study: NCT03824392
Study Brief: Study of Intravenous ATYR1923 (Efzofitimod) for Pulmonary Sarcoidosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received placebo matched to efzofitimod via IV infusion every 4 weeks until Week 20. 0 None 1 12 10 12 View
Efzofitimod 1.0 mg/kg Participants received efzofitimod 1.0 mg/kg via IV infusion every 4 weeks until Week 20. 0 None 1 8 8 8 View
Efzofitimod 3.0 mg/kg Participants received efzofitimod 3.0 mg/kg via IV infusion every 4 weeks until Week 20. 0 None 0 8 7 8 View
Efzofitimod 5.0 mg/kg Participants received efzofitimod 5.0 mg/kg via IV infusion every 4 weeks until Week 20. 0 None 0 9 8 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cholecystitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Streptococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dyspnoea at rest NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Productive cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pulmonary sarcoidosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Feeling hot NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Vaccination site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Abdominal wall abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Sputum purulent NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Candida infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Metapneumovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Osteoporosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Burning sensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Disturbance in attention NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Abdominal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Salivary gland mass NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Lymphocyte count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Activated partial thromboplastin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Electrocardiogram T wave abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Eosinophil count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Laboratory test abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Neutrophil count increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Protein urine present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Prothrombin time prolonged NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Biopsy skin NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Breath sounds abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Mean cell volume increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Oxygen saturation decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Narrow anterior chamber angle NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Scleritis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Dry eye NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Bone contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Facial bones fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Metabolic disorder NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypertriglyceridaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash pruritic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Sarcoidosis NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Ovarian cyst ruptured NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Feeling jittery NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View