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 @ 12:59 PM

Ignite Modification Date: 2025-12-25 @ 12:19 PM

NCT ID: NCT00651261

Description: 709 participants were evaluated for adverse events.

Frequency Threshold: 0

Time Frame: None

Study: NCT00651261

Study Brief: Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid 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

Induction and Consolidation Chemotherapy Plus Midostaurin	Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.	None	None	157	355	321	355	View
Induction and Consolidation Chemotherapy Plus Placebo	Patients will receive daunorubicin 60 mg/m\^2 by IV push days 1-3 plus cytarabine 200 mg/m\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\^2) days 1, 3, \& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.	None	None	154	354	324	354	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Dyspepsia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Blood disorder	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 6	View
Bone marrow hypocellular	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	MedDRA 6	View
Disseminated intravascular coagulation	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
Arrhythmia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Asystole	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
Atrial tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Cardiac disorder	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Cardiac pain	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Cardiopulmonary arrest	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Conduction 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
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
Pericarditis	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Right ventricular dysfunction	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Sinus arrhythmia	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
Supraventricular tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Ventricular fibrillation	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Ventricular 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
External ear pain	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
Optic nerve edema	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 6	View
Photophobia	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 6	View
Retinal detachment	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 6	View
Scleral disorder	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 6	View
Vision blurred	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 fistula	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Anal hemorrhage	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
Anal ulcer	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Ascites	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Colitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Colonic hemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Colonic perforation	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 necrosis	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
Endoscopy small intestine abnormal	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Enteritis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Esophageal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Esophageal ulcer	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
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
Hemorrhoidal hemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Hemorrhoids	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Ileal hemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Ileal necrosis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Ileus	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Intestinal necrosis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Intra-abdominal hemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Jejunal necrosis	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
Periodontal disease	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 obstruction	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
Typhlitis	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
Disease progression	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
General symptom	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 6	View
Ill-defined disorder	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 6	View
Injection site reaction	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 6	View
Localized edema	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 6	View
Multi-organ failure	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 6	View
Pain	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 6	View
Sudden death	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 6	View
Visceral edema	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 6	View
Cholecystitis	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA 6	View
Hepatic failure	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	MedDRA 6	View
Hepatobiliary disease	SYSTEMATIC_ASSESSMENT	Hepatobiliary 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
Anal 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
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
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
Infectious colitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Joint infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Kidney infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Lip infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Lymph gland 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
Paranasal sinus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Penile infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Pharyngitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Phlebitis infective	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Pleural infection	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
Splenic infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Tooth infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Upper aerodigestive tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Vulval infection	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
Gastrointestinal anastomotic leak	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Intraoperative complications	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Intraoperative gastrointestinal injury	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Intraoperative gastrointestinal injury - Appendix	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Intraoperative reproductive tract injury - Ovary	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Intraoperative reproductive tract injury - Testis	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Kidney anastomotic leak	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Postoperative hemorrhage	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
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 T increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 6	View
Coagulopathy	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 6	View
Creatinine increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 6	View
Electrocardiogram QTc interval prolonged	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 6	View
Fibrinogen decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 6	View
Gamma-glutamyltransferase increased	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
Anorexia	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
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 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
Joint effusion	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 6	View
Muscle weakness	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
Neck pain	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
Ataxia	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
Intracranial hemorrhage	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 6	View
Ischemia cerebrovascular	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
Seizure	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
Syncope vasovagal	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
Personality change	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA 6	View
Psychosis	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA 6	View
Bladder hemorrhage	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 6	View
Bladder pain	SYSTEMATIC_ASSESSMENT	Renal and urinary 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
Proteinuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 6	View
Renal failure	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 6	View
Renal hemorrhage	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 6	View
Ureteric obstruction	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
Penile pain	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	MedDRA 6	View
Perineal pain	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	MedDRA 6	View
Reproductive tract disorder	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	MedDRA 6	View
Uterine hemorrhage	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	MedDRA 6	View
Vaginal hemorrhage	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	MedDRA 6	View
Vaginal mucositis	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
Bronchopulmonary hemorrhage	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
Laryngeal edema	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Laryngeal mucositis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Laryngeal pain	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Laryngoscopy abnormal	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Nasal congestion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Pharyngeal examination abnormal	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
Pneumothorax	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Pulmonary hemorrhage	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Pulmonary hypertension	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
Retinoic acid syndrome	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Tracheal stenosis	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
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 ulceration	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 6	View
Sweating	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
Lymphangitic streak	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 6	View
Lymphedema	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
Vasculitis	SYSTEMATIC_ASSESSMENT	Vascular 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
Disseminated intravascular coagulation	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
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
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
Atrial tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Cardiac disorder	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Cardiac pain	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Cardiac valve disease	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Conduction disorder	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
Pericarditis	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Premature ventricular contractions	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
Supraventricular extrasystoles	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Supraventricular tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Ventricular arrhythmia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Ventricular bigeminy	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Ventricular fibrillation	SYSTEMATIC_ASSESSMENT	Cardiac disorders	MedDRA 6	View
Ventricular 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
External ear inflammation	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
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
Optic nerve disorder	SYSTEMATIC_ASSESSMENT	Eye disorders	MedDRA 6	View
Photophobia	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 fistula	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Anal hemorrhage	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
Anal ulcer	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Ascites	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Colitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Colonic hemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Colonic perforation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Dental prosthesis user	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
Dysphagia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Ear, nose and throat examination abnormal	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Endoscopy large bowel abnormal	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Enteritis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Esophageal mucositis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Esophageal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Esophageal perforation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Esophageal ulcer	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
Gastric mucositis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Gastric ulcer	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
Gastroscopy abnormal	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Gingival pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Hemorrhoidal hemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Hemorrhoids	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Ileal obstruction	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Ileus	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Large intestinal mucositis	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
Oesophagoscopy abnormal	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
Periodontal disease	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Peritoneal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Proctitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Proctoscopy abnormal	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Rectal hemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Rectal obstruction	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
Small intestinal mucositis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Stomach pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Tooth development disorder	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Tooth disorder	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Toothache	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA 6	View
Typhlitis	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
Disease progression	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
Hypothermia	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 6	View
Ill-defined disorder	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 6	View
Injection site reaction	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 6	View
Localized edema	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 6	View
Pain	SYSTEMATIC_ASSESSMENT	General disorders	MedDRA 6	View
Visceral edema	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
Hepatobiliary disease	SYSTEMATIC_ASSESSMENT	Hepatobiliary 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
Anal 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
Cecal 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
Device related infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Eye 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
Infectious colitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Kidney infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Lip infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Lymph gland infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Mediastinal 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 media	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Paranasal sinus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Penile infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Pharyngitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Phlebitis infective	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
Scrotal 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
Soft tissue infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA 6	View
Splenic 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
Vulval infection	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
Device complication	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Injury to inferior vena cava	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Injury to jugular vein	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Intraoperative complications	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Intraoperative gastrointestinal injury	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Intraoperative gastrointestinal injury - Teeth	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Intraoperative head and neck injury - Neck NOS	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Intraoperative ocular injury - Lens	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Postoperative hemorrhage	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Radiation recall reaction (dermatologic)	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Thermal burn	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Tracheostomy site bleeding	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA 6	View
Vaginal anastomotic leak	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-lower	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
Cardiac troponin T increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 6	View
Coagulopathy	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 6	View
Creatinine increased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 6	View
Electrocardiogram QTc interval prolonged	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 6	View
Fibrinogen decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 6	View
Forced expiratory volume decreased	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 6	View
Gamma-glutamyltransferase increased	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 gain	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 6	View
Weight loss	SYSTEMATIC_ASSESSMENT	Investigations	MedDRA 6	View
Alkalosis	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	MedDRA 6	View
Anorexia	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
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
Joint disorder	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 6	View
Joint effusion	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 6	View
Joint range of motion decreased lumbar spine	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
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
Osteoporosis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 6	View
Pain in extremity	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 6	View
Upper extremity dysfunction	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	MedDRA 6	View
Myelodysplasia	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	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
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
Intracranial hemorrhage	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
Olfactory nerve disorder	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
Pyramidal tract syndrome	SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA 6	View
Seizure	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
Syncope vasovagal	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
Personality change	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA 6	View
Psychosis	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	MedDRA 6	View
Bladder hemorrhage	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 6	View
Bladder pain	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 6	View
Bladder spasm	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 6	View
Cystitis	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	MedDRA 6	View
Hemoglobin urine positive	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 obstruction	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
Gynecomastia	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
Reproductive tract disorder	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	MedDRA 6	View
Uterine hemorrhage	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	MedDRA 6	View
Uterine pain	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	MedDRA 6	View
Vaginal discharge	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	MedDRA 6	View
Vaginal hemorrhage	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	MedDRA 6	View
Vaginal inflammation	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	MedDRA 6	View
Vaginal mucositis	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
Atelectasis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Bronchopulmonary hemorrhage	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
Hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Laryngeal edema	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Laryngeal mucositis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Laryngeal pain	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Laryngoscopy abnormal	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Nasal congestion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Pharyngeal examination abnormal	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Pharyngeal mucositis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Pharyngeal stenosis	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
Pneumonitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Pneumothorax	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA 6	View
Pulmonary fibrosis	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
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
Photosensitivity	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
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 induration	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	MedDRA 6	View
Skin striae	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
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
Vasculitis	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 6	View
Visceral arterial ischemia	SYSTEMATIC_ASSESSMENT	Vascular disorders	MedDRA 6	View