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 @ 3:00 PM
Ignite Modification Date: 2025-12-25 @ 1:24 PM
NCT ID: NCT00602459
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00602459
Study Brief: Fludarabine and Rituximab With or Without Lenalidomide or Cyclophosphamide in Treating Patients With Symptomatic Chronic Lymphocytic Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A (Rituximab, Fludarabine Phosphate) Participants receive induction therapy (every 28 days for up to 6 cycles) of: Patients receive rituximab IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5. None None 13 123 117 123 View
Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide) Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 1-4 hours on days 1 (50 mg/m\^2), 3 (325 mg/m\^2), and 5 (375 mg/m\^2) of course 1 and on day 1 (375 mg/m\^2) of all subsequent courses. Patients also receive fludarabine phosphate 25 mg/m\^2/day IV over 30 minutes or PO on days 1-5. Participants without progression receive consolidation therapy lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6 PO QD on days 1-21 of 28 day cycle. None None 21 109 107 109 View
Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide) Participants receive induction therapy (every 28 days for up to 6 cycles) of: rituximab IV over 4 hours on days 1 (50mg/m\^2) and 3 (325 mg/m\^2) of course 1 and on day 1 (500 mg/m\^2) of all subsequent courses. Patients then receive fludarabine phosphate (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) followed by cyclophosphamide (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) IV piggyback over 30 minutes on days 1-3. None None 14 137 132 137 View
Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide) Patients receive the first course of induction therapy as in Arm A or B before being re-assigned to Arm D. Beginning in course 2, patients receive rituximab IV (500 mg/m\^2) on day 1 and fludarabine phosphate (age \< 70: 25 mg/m\^2/day; age \>= 70: 20 mg/m\^2/day) IV piggyback over 30 minutes or PO (32 mg/m\^2/day) and cyclophosphamide IV (age \< 70: 250 mg/m\^2/day; age \>= 70: 150 mg/m\^2/day) piggyback over 30 minutes on days 1-3. Participants without progression receive consolidation therapy: lenalidomide 5mg/day cycle 1, 10 mg/day cycles 2-6PO QD on days 1-21 of 28 day cycle. None None 3 31 30 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Lymphatic disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Premature ventricular contractions SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Ear disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Gastric perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Periodontal disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Death NOS SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Joint infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Peripheral nerve infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Vulvitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Carbon monoxide diffusing capacity decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Electrocardiogram QTc interval prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Haptoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
INR increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Laboratory test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Serum cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Renal tubular disorder SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum calcium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum glucose decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum magnesium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum magnesium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum potassium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness left-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Treatment related secondary malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 6 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 6 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urethral pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urogenital disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Sinus pain SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Personality change SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Hemoglobin urine positive SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Lymphatic disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Thrombotic microangiopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Conduction disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Edema SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Premature ventricular contractions SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Restrictive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Ventricular bigeminy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Ear disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
External ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Middle ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Endocrine disorder SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 6 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 6 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 6 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Dry eye syndrome SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Eye disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Eyelid function disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Flashing vision SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Vitreous hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Anal exam abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Anal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Anal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Colonic fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Duodenal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Oral hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Peritoneal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Salivary gland disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Tooth disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Gait abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
General symptom SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Pericardial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 6 View
Gallbladder pain SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 6 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 6 View
Autoimmune disorder SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Immune system disorder SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Anorectal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Bone infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Colitis, infectious (e.g., Clostridium difficile) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Conjunctivitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Corneal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Esophageal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Eye infection intraocular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Gallbladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Gastric infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Gingival infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Hepatic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Infection with unknown ANC SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Infectious meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Joint infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Lip infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Opportunistic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Penile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Peripheral nerve infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Rhinitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Salivary gland infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Small intestine infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Upper aerodigestive tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Ureteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Viral hepatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Vulvitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6 View
Intraoperative neurological injury - NERVES: Sciatic SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6 View
Venous injury - Extremity-upper SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Electrocardiogram QTc interval prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Haptoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
INR increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Laboratory test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Serum cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Glucose intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Iron overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum calcium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum glucose decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum magnesium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum magnesium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum potassium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum sodium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum triglycerides increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Tumor lysis syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Buttock pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Fibrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Fibrosis deep connective tissue SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Joint disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness right-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Musculoskeletal disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Neck soft tissue necrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Trismus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Treatment related secondary malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 6 View
Tumor flare SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 6 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 6 View
Acoustic nerve disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Cerebrospinal fluid leakage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Neurological disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Nystagmus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Phrenic nerve paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Sinus pain SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Euphoria SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Hemorrhage urinary tract SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Kidney pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urethral pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urine discoloration SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urogenital disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Perineal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Prostatic obstruction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Reproductive tract disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Scrotal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Testicular pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Vaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Vaginal hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Vaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Adult respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pharyngeal hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pharyngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Respiratory tract hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Hand-and-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Scalp pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Telangiectasia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Lymphocele SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View