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 @ 3:55 PM
Ignite Modification Date: 2025-12-25 @ 2:00 PM
NCT ID: NCT00992992
Description: None
Frequency Threshold: 0
Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until 4 weeks following the last cycle of CHOP, or until administration of alternative therapy, whichever came first (average of 77.8 months).
Study: NCT00992992
Study Brief: Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody Plus CHOP For Untreated Mantle Cell 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
Iodine I-131 Tositumomab + CHOP Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams \[mg\]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy). None None 19 25 25 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Endometrial adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Malignant melanoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Malignant melanoma in situ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Oesophageal adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Plasma cell myeloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Squamous cell carcinoma 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
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Peroneal nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Intussusception SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Anorectal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Faecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Post herpetic neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
WBC < 2000 cells/mm^3 SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Absolute neutrophil count (CALC) < 1000 cells/mm^3 SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hemoglobin < 8.0 grams per deciliter (g/dL) SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nephrotic syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Tooth fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Antibody test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Halo vision SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Cardiac septal defect SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Early satiety SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Local swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Glossitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oral discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Upper respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Sputum discoloured SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Platelets <50000 cells/millimeters cubed (mm^3) SYSTEMATIC_ASSESSMENT Investigations MedDRA View