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 @ 1:41 PM
Ignite Modification Date: 2025-12-25 @ 12:37 PM
NCT ID: NCT03205995
Description: {Not specified}
Frequency Threshold: 0
Time Frame: From Day 1 to Final Study Visit (up to Day 771)
Study: NCT03205995
Study Brief: Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OMS721 (Narsoplimab) Administration of OMS721 (narsoplimab) OMS721 (narsoplimab): Intravenous loading dose followed by daily subcutaneous injections 1 None 5 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
RENAL GRAFT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
ESCHERICHIA SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
CEREBRAL HEMATOMA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
HAEMOLYSIS SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
CHRONIC ALLOGRAFT NEPHROPATHY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25 View
KIDNEY TRANSPLANT REJECTION SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25 View
CHRONIC KIDNEY DISEASE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
ARTERIOVENOUSE FISTULA ANEURYSM SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
HEPATIC FAILURE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 25 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
SHUNT BLOOD FLOW EXCESSIVE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
PULMONARY HYPERTENSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
PURPURA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
HAEMOLYSIS SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
IRON DEFICIENCY ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
HYPERTROPHIC CARDIOMYOPATHY SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 25 View
ADRENAL INSUFFICIENCY SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25 View
HYPERTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25 View
ASCITES SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
ENTEROCOLITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
OESOPHAGEAL ULCER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
INJECTION SITE EXTRAVASATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
INJECTION SITE HAEMATOMA SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
INJECTION SITE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
CHRONIC ALLOGRAFT NEPHROPATHY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25 View
HYPERSENSITIVITY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25 View
KIDNEY TRANSPLANT REJECTION SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25 View
ARTERIOVENOUS FISTULA SITE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
BACTERIAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
CLOSTRIDIUM DIFFICILE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
MOLLUSCUM CONTAGIOSUM SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
RENAL GRAFT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
UREAPLASMA INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
URINARY TRACT INFECTION ENTEROCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
ARTERIOVENOUS FISTULA ANEURYSUM SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
POST PROCEDURAL HAEMATOMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
SHUNT BLOOD FLOW EXCESSIVE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
SUBDURAL HAEMATOMA SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
BLOOD CHOLESTEROL INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
C-REACTIVE PROTEIN INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
ELECTROCARDIOGRAM QT PROLONGED SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
HUMAN CHORIONIC GONADOTROPIN ABNORMAL SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
TREPONEMA TEST POSITIVE SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
HYPERKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
HYPERPHOSPHATAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
HYPERURICAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
HYPOCALCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
EPILEPSY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
NEUROLOGICAL SYMPTOM SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
AGRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25 View
CHRONIC KIDNEY DISEASE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
HAEMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
LEUKOCYTURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
AMENORRHOEA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
PURPURA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 25 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 25 View