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 @ 10:08 PM
Ignite Modification Date: 2025-12-25 @ 7:44 PM
NCT ID: NCT00070135
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00070135
Study Brief: Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplant in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Fludarabine, Busulfan, Allogeneic PBSC) PREPARATIVE REGIMEN: Patients receive fludarabine 30 mg/m\^2 IV over 30 minutes on days -7 to -3 and busulfan 0.8 mg/kg IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3. GVHD PROPHYLAXIS: Patients receive tacrolimus 0.03 mg/kg (suggested starting dose) PO BID on days -2 with taper between days 90-120, and stopping by days 150-180. Patients also receive methotrexate 5 mg/m\^2 IV on days 1, 3, 6, and 11 and rabbit antithymocyte globulin 2.5 mg/kg IV over 4-6 hours on days -4 through -2. ALLOGENEIC PBSC: Patients undergo allogeneic PBSC transplant on day 0. Patients then receive filgrastim 5 or 10 mcg/kg SC daily beginning on day 12 and continuing until blood counts recover None None 38 114 109 114 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac pain SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Cardiopulmonary arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Blood disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Atrial fibrillation 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
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Ear disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 6 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 6 View
Dry eye syndrome 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
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Ear, nose and throat examination abnormal 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
Lower gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Mucositis oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Tooth disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Death NOS SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
General symptom SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Ill-defined disorder 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
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
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
Encephalitis 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
Lip infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Opportunistic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Paranasal sinus infection 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
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
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Vascular access complication 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
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Creatinine 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
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
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
Arthralgia 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
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness left-sided SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness right-sided 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
Scoliosis 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
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
Facial nerve 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
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Psychosis SYSTEMATIC_ASSESSMENT Psychiatric 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
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Kidney pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urethral pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Pelvic floor muscle weakness SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Scrotal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Vaginal inflammation 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
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Nasal congestion 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
Respiratory disorder 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
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
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
Thrombosis 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
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Hemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Lymphatic disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
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
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Ear disorder SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
External ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Hearing impaired SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 6 View
Adrenal insufficiency 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
Extraocular muscle paresis 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
Optic nerve disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Retinal detachment 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 pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Ear, nose and throat examination abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Fecal incontinence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Flatulence 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
Hemorrhoidal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Lip pain 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
Blood glucose increased 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
Abdominal soft tissue necrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Chest wall pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Fibrosis deep connective tissue SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Joint disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Musculoskeletal disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
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
Treatment related secondary malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 6 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Dysgeusia 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
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Sinus pain SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Psychosis SYSTEMATIC_ASSESSMENT Psychiatric 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
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
Urethral stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Urogenital disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Irregular menstruation SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Perineal pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Scrotal 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 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
Apnea 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
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 hemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pharyngeal mucositis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pneumothorax 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
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
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 hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue 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
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Rectal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Typhlitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Edema limbs SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Fever 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
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Bladder 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
Conjunctivitis infective 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
Ileal 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
Infectious meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Lip 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
Pneumonia 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
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Viral hepatitis 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
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
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
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Electrocardiogram QTc interval prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
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
Anorexia 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
Iron overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum albumin decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum calcium decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum calcium increased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Serum glucose decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View