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 @ 11:33 PM
Ignite Modification Date: 2025-12-25 @ 9:22 PM
NCT ID: NCT03473756
Description: None
Frequency Threshold: 0
Time Frame: Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days
Study: NCT03473756
Study Brief: Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rogaratinib 800 mg BID + Atezolizumab Participants receiving 800 mg Rogaratinib twice daily plus Atezolizumab 9 None 8 11 11 11 View
Rogaratinib 600 mg BID + Atezolizumab Participants receiving 600 mg Rogaratinib twice daily plus Atezolizumab 11 None 14 26 26 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Diarrhoea haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Gastrointestinal vascular malformation haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Renal function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Chronic lymphocytic leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Tumour haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Renal cyst aspiration SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 27.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Neutrophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Hypereosinophilic syndrome SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 27.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Keratopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Maculopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Photopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Detachment of retinal pigment epithelium SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Xerophthalmia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Corneal toxicity SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Ocular rosacea SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Detachment of macular retinal pigment epithelium SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Meibomian gland dysfunction SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Retinoschisis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Serous retinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Oral lichen planus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Anal erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Tongue erosion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Rectal discharge SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Hyperpyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Early satiety SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Secretion discharge SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Atypical pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Onychomycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Anorectal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Herpes dermatitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Subcutaneous haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Klebsiella urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Gastrointestinal viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Stoma site ulcer SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Stoma site inflammation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Post-traumatic pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Post procedural fever SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Chest injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Amylase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood thyroid stimulating hormone decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood potassium increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood phosphorus increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Lipase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
N-terminal prohormone brain natriuretic peptide increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Calcium phosphate product increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Renal function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Electrocardiogram ST-T segment abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyperlipasaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypercreatininaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Groin pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Tendon pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Hyperaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Hypotonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Taste disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Memory impairment SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Personality change SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Renal pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Leukocyturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.0 View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.0 View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Lower respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Nasal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.0 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Nail discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Hyperkeratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Nail dystrophy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Palmar erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Onycholysis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Nail hypertrophy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Xeroderma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Onychomadesis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Diabetic foot SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Nail bed inflammation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27.0 View
Astringent therapy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 27.0 View
Erythromelalgia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Thrombosis in device SYSTEMATIC_ASSESSMENT Product Issues MedDRA 27.0 View