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
| 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 |
| 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 |
| 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 |