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 @ 2:52 AM
Ignite Modification Date: 2025-12-26 @ 1:33 AM
NCT ID: NCT02999633
Description: Reported Adverse events (AEs) are treatment emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from first study treatment administration until 30 days after the last administration of study treatment). Safety analysis set included all participants who received at least 1 dose of isatuximab.
Frequency Threshold: 5
Time Frame: Baseline up to 30 days after last dose of study drug administration (up to maximum of 12.1 weeks)
Study: NCT02999633
Study Brief: Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Isatuximab Participants received intravenous administration of isatuximab at a dose of 20 mg/kg at Day 1, 8, 15 and 22 of each Cycle (up to 2 treatment cycles, each cycle 28 days). 6 None 10 14 12 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.1 View
Pericarditis Constrictive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.1 View
Disease Progression SYSTEMATIC_ASSESSMENT General disorders MedDra 20.1 View
Device Related Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.1 View
Fungal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.1 View
Periorbital Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.1 View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Pulmonary Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Pelvic Venous Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.1 View
Vein Collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 20.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 20.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra 20.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra 20.1 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 20.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDra 20.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDra 20.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 20.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 20.1 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 20.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDra 20.1 View
Cytokine Release Syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDra 20.1 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.1 View
Device Related Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.1 View
Oral Herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.1 View
Pyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 20.1 View
Infusion Related Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 20.1 View
Body Temperature Increased SYSTEMATIC_ASSESSMENT Investigations MedDra 20.1 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDra 20.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.1 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.1 View
Flank Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.1 View
Muscle Oedema SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.1 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.1 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra 20.1 View
Facial Paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.1 View
Peripheral Motor Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 20.1 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDra 20.1 View
Bronchitis Chronic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Bronchostenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Pharyngeal Erythema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 20.1 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDra 20.1 View