Adverse Events Module

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 @ 4:51 PM
Ignite Modification Date: 2025-12-25 @ 2:35 PM
NCT ID: NCT00265850
Description: Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
Frequency Threshold: 0
Time Frame: None
Study: NCT00265850
Study Brief: Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
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 B: FOLFOX or FOLFIRI + Cetuximab Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours. None None 111 578 548 578 View
Arm A: FOLFOX or FOLFIRI + Bevacizumab Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours. None None 98 559 531 559 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Duodenal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Ileal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Jejunal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Obstruction gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Small intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Death NOS SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 5 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 5 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 5 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Ileal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Arterial injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 5 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 5 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 5 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Carbon monoxide diffusing capacity decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Cardiac troponin I increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Serum cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum glucose decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum magnesium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum potassium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum sodium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Ischemia cerebrovascular SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Hand-and-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Eye disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 5 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 5 View
Thrombotic microangiopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 5 View
Arrhythmia supraventricular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Nodal arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Ventricular trigeminy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Ear disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 5 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 5 View
External ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 5 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 5 View
Hearing test abnormal SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 5 View
Middle ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 5 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 5 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 5 View
Cushingoid SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 5 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 5 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 5 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Dry eye syndrome SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Extraocular muscle paresis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Eye disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Eyelid function disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 5 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Anal exam abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Anal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Anal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Anal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Colonic fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Colonic hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Duodenal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Duodenal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Duodenal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Endoscopy small intestine abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Esophageal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Esophageal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Fecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Fistula of small intestine SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Gastric stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Ileal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Intestinal necrosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Jejunal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Lip pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Obstruction gastric SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Oral hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Periodontal disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Peritoneal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Rectal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Rectal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Rectal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Salivary gland disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Small intestinal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Small intestinal necrosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Small intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Small intestine ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Tooth disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 5 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Gait abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
General symptom SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Pericardial pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 5 View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 5 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 5 View
Gallbladder pain SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 5 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 5 View
Hepatobiliary disease SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 5 View
Portal hypertension SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 5 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 5 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 5 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Anal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Anorectal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Biliary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Bone infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Colitis, infectious (e.g., Clostridium difficile) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Conjunctivitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Esophageal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Gingival infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Infection with unknown ANC SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Infection without neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Infectious colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Infectious meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Joint infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Lip infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Lymph gland infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Mediastinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Mucosal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Opportunistic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Paranasal sinus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Pelvic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Penile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Peripheral nerve infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Peritoneal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Rhinitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Salivary gland infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Scrotal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Small intestine infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Stoma site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Upper aerodigestive tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Urethral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Wound-infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 5 View
Aortic injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 5 View
Arterial injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 5 View
Esophageal anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 5 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 5 View
Intestinal stoma site bleeding SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 5 View
Intraoperative gastrointestinal injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 5 View
Radiation recall reaction (dermatologic) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 5 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 5 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 5 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 5 View
Activated partial thromboplastin time prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Alkaline phosphatase SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Blood gonadotrophin abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Cardiac troponin T increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Coagulopathy SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Electrocardiogram QTc interval prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Fibrinogen decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
INR increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Laboratory test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Serum cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 5 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Glucose intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum calcium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum glucose decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum magnesium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum magnesium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum phosphate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum potassium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum potassium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum sodium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum sodium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Serum triglycerides increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 5 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Buttock pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Joint disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Musculoskeletal disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Soft tissue necrosis upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Trismus SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Upper extremity dysfunction SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 5 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 5 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Facial nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Ischemia cerebrovascular SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Mini mental status examination abnormal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Neurological disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Recurrent laryngeal nerve palsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Sinus pain SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Syncope vasovagal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Trigeminal nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 5 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 5 View
Bladder hemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Bladder pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Bladder spasm SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Hemoglobin urine positive SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Hemorrhage urinary tract SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Kidney pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Kidney perforation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Renal hemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Ureteric hemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Ureteric obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Ureteric stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Urogenital disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 5 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 5 View
Gynecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 5 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 5 View
Prostatic obstruction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 5 View
Vaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 5 View
Vaginal fistula SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 5 View
Vaginal hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 5 View
Vaginal inflammation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 5 View
Vaginal mucositis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 5 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Dyspnea (shortness of breath) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Laryngeal edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pharyngeal examination abnormal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pharyngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pleural hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Respiratory tract hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Tracheoscopy abnormal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 5 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Body odor SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Hand-and-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Rash/dermatitis associated with high-dose chemotherapy or BMT studies. SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Scalp pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Skin induration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 5 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Lymph leakage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Lymphedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 5 View
Blood disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 5 View
Disseminated intravascular coagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 5 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 5 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 5 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 5 View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 5 View
Lymphatic disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 5 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Cardiac pain SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Conduction disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 5 View