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 @ 12:32 PM
Ignite Modification Date: 2025-12-25 @ 12:09 PM
NCT ID: NCT01536561
Description: None
Frequency Threshold: 0
Time Frame: Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.
Study: NCT01536561
Study Brief: Study of Radiolabeled Monoclonal Antibody Anti-B1 for the Treatment of B-Cell Lymphomas and Extended Study to Determine the Safety and Efficacy of Coulter Clone® 131Iodine-B1 Radioimmunotherapy of Advanced Non-Hodgkin's Lymphoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TST and Iodine I 131 TST: Initial Treatment Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. None None 17 59 55 59 View
TST and Iodine I 131 TST: Retreatment After the "Initial Treatment" (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:\>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the "Initial Treatment." Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study. None None 7 14 12 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myelodysplastic Syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Acute Myeloid Leukemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Bladder Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Squamous Cell Carcinoma of Skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Anal Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Carcinoid Tumour Pulmonary SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Hemangioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Lip and/or Oral Cavity Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Renal Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Serum Sickness SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Anaphylactic Reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Anaphylactoid Reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Hemophilus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia Streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Necrotising Panniculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Axillary Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Catheter Site Rash SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Ill-Defined Disorder SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infusion Site Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Infusion Site Phlebitis SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Medical Device Complication SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mucous Membrane Disorder SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhea Hemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Fecal Incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Paraesthesia Oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
White Blood Cells < 2000 cells/cm^3 SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Absolute Neutrophil Count <1000 cells/cm^3 SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Platelets <50000 cells/cm^3 SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hemoglobin <8.0 g/dL SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Postoperative Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Vestibular Neuronitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Skin Irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Flank Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal Stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea Exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal Dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal Ulcer SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye Irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Oliguria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Ureteric Obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Bladder Pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ear Discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Ear Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Liver Function Test Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Infusion Site Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal Discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tachypnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Throat Irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Serum Sickness SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Sinus Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes Zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View