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 @ 3:24 PM
Ignite Modification Date: 2025-12-25 @ 1:42 PM
NCT ID: NCT01359592
Description: The total number or participants at risk in this section is the number or participants in each arm that are eligible and evaluable.
Frequency Threshold: 0
Time Frame: up to 4 months or time of disease progression
Study: NCT01359592
Study Brief: S1001 PET-Directed Therapy in Treating Patients With Limited-Stage Diffuse Large B-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
R-CHOP x 3 Chemotherapy for up to 3 cycles, 21 days/per cycle, with R-CHOP For each cycle, R-CHOP therapy included: Rituximab: 375 mg/m\^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m\^2 IV administration on Day 1 Doxorubicin: 50 mg/m\^2 IV administration on Day 1 Vincristine: 1.4 mg/m\^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 1 None 2 132 130 132 View
R-CHOP x 6 Chemotherapy for up to 6 cycles, 21 days/per cycle, with R-CHOP For each cycle, R-CHOP therapy included: Rituximab: 375 mg/m\^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m\^2 IV administration on Day 1 Doxorubicin: 50 mg/m\^2 IV administration on Day 1 Vincristine: 1.4 mg/m\^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 0 None 0 1 1 1 View
PET-negative: R-CHOP x 1 Chemotherapy for 1 cycle, 21 days/per cycle, with R-CHOP R-CHOP therapy included: Rituximab: 375 mg/m\^2 IV administration on Day 1 Cyclophosphamide: 750 mg/m\^2 IV administration on Day 1 Doxorubicin: 50 mg/m\^2 IV administration on Day 1 Vincristine: 1.4 mg/m\^2 (maximum 2 mg) IV administration on Day 1 Prednisone: 100 mg administered orally on Days 1 through 5 2 1 None 2 113 105 113 View
PET-positive: IFRT + Yttrium-90 Ibritumomab Tiuxetan (Zevalin®) Patients start Involved-Field Radiation Therapy (IFRT) as soon as possible after the Day 15-18 PET/CT scan that follows Cycle 3 of R-CHOP, but no later than Day 35 after initiation of Cycle 3 of R-CHOP. Zevalin® treatment begins 3-6 weeks after Radiation Therapy is completed. Radiation Therapy included: IFRT: 180 cGy/day for a minimum dose of 3600 cGy and a maximum of dose of 4500 cGy Radioimmunotherapy included: Rituximab: 250 mg/m\^2 IV administration on Day 1 then 7, 8, or 9 Yttrium-90 ibritumomab tiuxetan: 0.4 mCi/kg or 0.3 mCi/kg, absolute maximum allowable dose of 32.0 mCi, 10 min IV infusion, on Day 7, 8 or 9 0 None 0 12 11 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sudden death NOS SYSTEMATIC_ASSESSMENT General disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Resp, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Leukemia secondary to oncology chemotherapy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood and lymphatic system disorders - Other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Endocrine disorders-Other SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye disorders-Other SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders None View
Floaters SYSTEMATIC_ASSESSMENT Eye disorders None View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophageal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorders-Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoidal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Edema face SYSTEMATIC_ASSESSMENT General disorders None View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders None View
Facial pain SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders None View
General disorders and admin site conditions - Other SYSTEMATIC_ASSESSMENT General disorders None View
Infusion related reaction SYSTEMATIC_ASSESSMENT General disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Localized edema SYSTEMATIC_ASSESSMENT General disorders None View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Autoimmune disorder SYSTEMATIC_ASSESSMENT Immune system disorders None View
Bronchial infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gum infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hepatitis viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infections and infestations-Other SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lip infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Papulopustular rash SYSTEMATIC_ASSESSMENT Infections and infestations None View
Peripheral nerve infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations None View
Carbon monoxide diffusing capacity decreased SYSTEMATIC_ASSESSMENT Investigations None View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Investigations None View
Cholesterol high SYSTEMATIC_ASSESSMENT Investigations None View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations None View
Fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations None View
Forced expiratory volume decreased SYSTEMATIC_ASSESSMENT Investigations None View
Hemoglobin increased SYSTEMATIC_ASSESSMENT Investigations None View
INR increased SYSTEMATIC_ASSESSMENT Investigations None View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Vital capacity abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Weight gain SYSTEMATIC_ASSESSMENT Investigations None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell decreased SYSTEMATIC_ASSESSMENT Investigations None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Glucose intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle weakness left-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle weakness upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal and connective tiss disorder - Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neoplasms benign, malignant and unspecified - Other SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Concentration impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Movements involuntary SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nervous system disorders-Other SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal and urinary disorders-Other SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal calculi SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urine discoloration SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Irregular menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Reproductive system and breast disorders - Other SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hoarseness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Laryngeal edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Postnasal drip SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Resp, thoracic and mediastinal disorders - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nail discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nail ridging SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Periorbital edema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Scalp pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin and subcutaneous tissue disorders - Other SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Telangiectasia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Superficial thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View