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 @ 1:38 AM
Ignite Modification Date: 2025-12-25 @ 11:54 PM
NCT ID: NCT00560794
Description: Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those participants who received at least one dose of investigational product.
Frequency Threshold: 5
Time Frame: From the start of study treatment until up to 4 weeks after the end of study treatment. The median treatment duration was 87.3 days.
Study: NCT00560794
Study Brief: Phase II Study of the BiTE® Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Blinatumomab Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment. None None 10 21 21 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Medical device complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Bacterial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Thrombosis in device SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Catheter site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Monocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Growing pains SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Immunodeficiency SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Blood immunoglobulin G decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood immunoglobulin M decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Coagulation factor XIII level increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Fibrin D dimer increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Immunoglobulins decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Periorbital oedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood immunoglobulin A decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View