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 @ 4:30 AM
Ignite Modification Date: 2025-12-26 @ 3:33 AM
NCT ID: NCT00436618
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00436618
Study Brief: Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Relapsed Aggressive Non-Hodgkin Lymphoma Study 1. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. None None 38 114 113 114 View
Relapsed Indolent Non-Hodgkin Lymphoma Study 2. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. None None 11 55 55 55 View
Uncommon Lymphomas Study 3. Includes Hodgkin's lymphomas. Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time. None None 25 107 107 107 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Cardiopulmonary arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Restrictive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Intra-abdominal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10 View
Biliary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Colitis, infectious (e.g., Clostridium difficile) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Gingival infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Opportunistic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Ischemia cerebrovascular SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Urethral obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Adult respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Restrictive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10 View
Eye disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Proctoscopy abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
General symptom SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Ill-defined disorder SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Visceral edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10 View
Gallbladder obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Anal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Cecal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Colitis, infectious (e.g., Clostridium difficile) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Gastric infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Gingival infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Lip infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Penile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Pleural infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Upper aerodigestive tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Viral hepatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10 View
Radiation recall reaction (dermatologic) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Serum cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Glucose intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum glucose decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum potassium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Treatment related secondary malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 10 View
Accessory nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Ischemia cerebrovascular SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Mini mental status examination abnormal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Trigeminal nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Ureteric stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10 View
Adult respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Laryngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Laryngoscopy abnormal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pharyngeal examination abnormal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pharyngeal stenosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Pulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Radiculitis brachial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Cardiac pain SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10 View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10 View
Serum triglycerides increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Tumor lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10 View
Neurological disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10 View