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: 2025-12-25 @ 2:42 AM
Ignite Modification Date: 2025-12-26 @ 1:21 AM
NCT ID: NCT00866333
Description: None
Frequency Threshold: 0
Time Frame: First dose of study drug to within 30 days of last dose (Up to 34 months)
Study: NCT00866333
Study Brief: A Phase 2 Multi-Center Study of Entinostat (SNDX-275) in Patient With Relapsed or Refractory Hodgkin's Lymphoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Regimen 1: Entinostat 10 mg Regimen 1: entinostat 10 mg (two 5 mg tablets) orally, once every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. 0 None 2 16 16 16 View
Regimen 2: Entinostat 10 mg/15 mg Regimen 2: entinostat 10 mg (two 5 mg tablets) orally on Day 1, increased to 15 mg (three 5 mg tablets) beginning on Day 15 of Cycle 1 for participants who had not experienced treatment-related adverse events with severity grade ≥2 (moderate), then continue 15 mg every two weeks (Days 1 and 15) in a 28-day cycle until disease progression or unacceptable toxicity. 0 None 7 17 17 17 View
Regimen 3: Entinostat 15 mg Regimen 3: entinostat 15 mg (three 5 mg tablets), orally, once weekly for 3 weeks followed by a 1-week break in a 4-week (28-day) cycle until disease progression or unacceptable toxicity. 1 None 3 16 16 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.1 View
Liver abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Lung infection pseudomonal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Subdural haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Abdominal tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Faeces hard SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Gingivitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Tongue coated SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Tooth abscess SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Nasal ulcer SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pneumocystis jiroveci pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pneumonia klebsiella SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pulmonary alveolar haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Sinus headache SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Catheter thrombosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Crepitations SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Early satiety SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Exercise tolerance decreased SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Irritability SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Mucosal dryness SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Pitting oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Joint stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Contusion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Madarosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Skin candida SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Critical illness polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Facial paresis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Hyperaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Breath sounds abnormal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood creatinine SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Eosinophil percentage increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
International normalised ratio decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Monocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Cardiomegaly SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Pericardial rub SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Mood altered SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Pallor SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Lice infestation SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.1 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.1 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.1 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.1 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.1 View
Hyperparathyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.1 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Hepatomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10.1 View
Hypogammaglobulinaemia SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10.1 View
Transfusion reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10.1 View
Foreign body trauma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.1 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.1 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.1 View
Epididymitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.1 View
Scrotal oedema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.1 View
Ear infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Lymph node pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View