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 @ 3:49 AM
Ignite Modification Date: 2025-12-26 @ 2:37 AM
NCT ID: NCT01454102
Description: Adverse event data was only collected by cohort and not by dose. All participants in "Arm C10: Nivolumab (10 mg/kg) + Paclitaxel + Carboplatin" and "Arm C5: Nivolumab (5 mg/kg) + Paclitaxel + Carboplatin" were monitored for adverse events under a single "Arm C" as a cohort.
Frequency Threshold: 5
Time Frame: From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)
Study: NCT01454102
Study Brief: Study of Nivolumab (BMS-936558) in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) (CheckMate 012)
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 M: Nivolumab Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression None None 4 12 11 12 View
Arm B: Nivolumab + Pemetrexed + Cisplatin Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4 None None 10 15 15 15 View
Arm E: Nivolumab + Erlotinib Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression None None 11 21 21 21 View
Arm F: Nivolumab Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression None None 23 52 50 52 View
Arm A: Nivolumab + Gemcitabine + Cisplatin Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4 None None 4 12 12 12 View
Arm J: Nivolumab + Ipilimumab Chemotherapy-naive NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression None None 12 16 16 16 View
Arm K: Nivolumab In Squamous Histology Subjects (NSCLC) SQ subjects who completed \>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression None None 3 13 11 13 View
Arm L: Nivolumab In Non-squamous Histology Subjects (NSCLC) NSQ subjects who completed \>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression None None 4 13 13 13 View
Arm N: Nivolumab + Ipilimumab Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression None None 12 31 30 31 View
Arm O: Nivolumab + Ipilimumab Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity None None 21 40 33 40 View
Arm P: Nivolumab + Ipilimumab Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity None None 25 38 35 38 View
Arm Q: Nivolumab + Ipilimumab Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity None None 25 39 33 39 View
Arm C: Nivolumab + Paclitaxel + Carboplatin Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4 None None 17 29 29 29 View
Arm D: Nivolumab + Bevacizumab Maintenance NSQ subjects who completed \>= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression None None 3 12 11 12 View
Arm G: Nivolumab + Ipilimumab Chemotherapy-naive SQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression None None 6 9 9 9 View
Arm H: Nivolumab + Ipilimumab Chemotherapy-naive NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression None None 12 15 15 15 View
Arm I: Nivolumab + Ipilimumab Chemotherapy-naive SQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression None None 5 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Bandaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
Hypopituitarism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
Secondary adrenocortical insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
Blindness unilateral SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Uveitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Large intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Oesophageal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Small intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Tongue discolouration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Autoimmune hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Bile duct stenosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 19.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Radiation necrosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Latent autoimmune diabetes in adults SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Type 1 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Myositis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Skin cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Embolic cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Facial nerve disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Nervous system disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Vocal cord paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Nephritis allergic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Renal salt-wasting syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Bronchial obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pulmonary haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Respiratory acidosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Aortic stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Superior vena cava syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Miller fisher syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Laryngeal haemorrhage SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pleuritic pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Rales SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Sputum discoloured SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Sputum increased SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Vocal cord disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Dyshidrotic eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Exfoliative rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Hair texture abnormal SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Nail discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Onychoclasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Onychomadesis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Scab SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin hypertrophy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin hypopigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin mass SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin plaque SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Solar dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Swelling face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Arterial thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Vena cava thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastric disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Glossodynia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Periodontal disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Salivary hypersecretion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Sensitivity of teeth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Steatorrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Catheter site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Catheter site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Decreased activity SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Feeling cold SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Implant site oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Infusion site irritation SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pneumonia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Temperature intolerance SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Alpha haemolytic streptococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Angular cheilitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Body tinea SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Genital herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Herpes virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Metapneumovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Nail infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pilonidal cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Rash pustular SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Viral rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Contrast media reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Post procedural contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Procedural vomiting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Radiation pneumonitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Urinary retention postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Wrist fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood corticotrophin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood creatine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood thyroid stimulating hormone increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Breath sounds abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Creatinine renal clearance decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Csf protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Heart rate increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Thyroxine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Tri-iodothyronine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Troponin t increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Urine output decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypermagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Lactic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Coccydynia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Limb discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Osteoporosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Synovial cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Intracranial tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Malignant pleural effusion SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Metastases to meninges SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Autonomic neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Balance disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Brain oedema SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Hyperaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Peripheral motor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Abnormal dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Mental fatigue SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Mood altered SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Bladder pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Stress urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Tubulointerstitial nephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Urinary straining SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 19.0 View
Menopausal symptoms SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Penile haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Deafness unilateral SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
Autoimmune thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Eye swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Defaecation urgency SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Granulocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Polycythaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Hypophysitis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
Thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 19.0 View
Astigmatism SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Periorbital oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Anogenital dysplasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Energy increased SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Face oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Nodule SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Xerosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Autoimmune disorder SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Cystitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Blood thyroid stimulating hormone decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Periarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View