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 @ 10:22 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT00074035
Description: 34 participants were evaluable for adverse events
Frequency Threshold: 0
Time Frame: None
Study: NCT00074035
Study Brief: Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pentostatin pentostatin: 4 mg/m\^2 IV infusion over 20-30 min q 2 weeks None None 14 34 30 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Diarrhea 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
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal 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
General symptom 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
Hepatobiliary disease SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 6 View
Immune system disorder SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Catheter related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Infection without neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Opportunistic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Phlebitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 6 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Alkaline phosphatase 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
Coagulopathy SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Creatinine 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 loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Blood glucose 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 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
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Musculoskeletal disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Dizziness 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
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Personality change SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 6 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast 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
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Pruritus 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
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 6 View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Edema SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Dry eye syndrome SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Eye disorder SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry eye syndrome SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Extraocular muscle paresis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Hemoglobin decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 6 View
Arrhythmia supraventricular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Edema SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Myocardial ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 6 View
Cushingoid SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 6 View
Cataract 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
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 6 View
Vision blurred 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
Esophageal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 6 View
Esophagitis 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
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
Ill-defined disorder SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 6 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 6 View
Hepatobiliary disease SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 6 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Immune system disorder SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 6 View
Bladder infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Infection without neutropenia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Opportunistic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Upper respiratory infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Ureteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 6 View
Bruising 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 SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Bilirubin associated with graft versus host disease (GVHD) for BMT studies SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Creatinine increased 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
Blood glucose 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
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
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
Musculoskeletal disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 6 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Cognitive disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Neurological disorder NOS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 6 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system 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
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 6 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Rash/desquamation associated with graft versus host disease (GVHD) for BMT studies SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Skin ulceration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Flushing 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
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 loss SYSTEMATIC_ASSESSMENT Investigations MedDRA 6 View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Alkalosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 6 View
Renal failure 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
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 6 View
Reproductive tract disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast 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
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 6 View
Hypoxia 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
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 6 View
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