Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 3:54 PM
Ignite Modification Date: 2025-12-25 @ 1:59 PM
NCT ID: NCT00513292
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00513292
Study Brief: Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies None None 19 138 136 138 View
Arm B Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies None None 26 142 141 142 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Extraocular muscle paresis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Eyelid function disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Anal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Colonic hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 9 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Peripheral nerve infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
INR increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Laboratory test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Serum cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypernatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Musculoskeletal disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Neurological disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Taste alteration SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Irregular menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Adult respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Bronchopulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Hemorrhage nasal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Hand-and-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Thrombotic microangiopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Premature ventricular contractions SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Sinus arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 9 View
External ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Middle ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 9 View
Conjunctival disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Dry eye syndrome SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Extraocular muscle paresis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Eye disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Eyelid function disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Watering eyes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 9 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Anal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Endoscopy large bowel abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Esophageal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Gastric mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Salivary gland disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Tooth disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
General symptom SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Visceral edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Cytokine release syndrome SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 9 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 9 View
Immune system disorder SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 9 View
Anal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Gingival infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Infectious colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Peripheral nerve infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Aortic injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Dermatitis radiation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Intraoperative breast injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Pharyngeal anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Radiation recall reaction (dermatologic) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Laboratory test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Leukocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Weight gain SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Weight loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 9 View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypercalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 9 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Fibrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Joint disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Muscle weakness upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Musculoskeletal deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Musculoskeletal disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Neck soft tissue necrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Tumor pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 9 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Facial nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Hypoglossal nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Intracranial hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Leukoencephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Mini mental status examination abnormal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Neurological disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Olfactory nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Sinus pain SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Taste alteration SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Libido decreased SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 9 View
Bladder pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Hemoglobinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Hemorrhage urinary tract SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Kidney pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Urine discoloration SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Urogenital disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 9 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Irregular menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Lactation disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Ovulation pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Reproductive tract disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Uterine hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Vaginal dryness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Vaginal hemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Vaginal inflammation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Vaginal mucositis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Vaginal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 9 View
Allergic rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Bronchial hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Bronchopulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Hemorrhage nasal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Hiccough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Laryngeal edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Laryngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pharyngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Pulmonary hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Hand-and-foot syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Photosensitivity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Scalp pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Skin induration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Hemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Peripheral ischemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 9 View
Lymphatic disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Ear disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
External ear inflammation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 9 View
Anal mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Oral hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9 View
Ill-defined disorder SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 9 View
Rhinitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9 View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 9 View