Assess Efficacy and Safety of AZD6244 in Combination With... | NCT01750281

ID	Type	Description	Link
2012-003622-25	EudraCT Number

Label	Type	Description	Intervention Names
Selumetinib 75 mg twice daily +Docetaxel 75 mg/m2	Experimental	Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.	Drug: Selumetinib 75 mg Drug: Docetaxel 75 mg/m2
Selumetinib 75 mg twice daily + Docetaxel 60 mg/m2	Experimental	Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 60 mg/m2 intravenously administered on day 1 of each 21 day cycle.	Drug: Selumetinib 75 mg Drug: Docetaxel 60 mg/m2
Placebo twice daily + Docetaxel 75 mg/m2	Experimental	Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.	Drug: Docetaxel 75 mg/m2 Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Selumetinib 75 mg	Drug	Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.	Selumetinib 75 mg twice daily + Docetaxel 60 mg/m2

Measure	Description	Time Frame
Progression Free Survival (PFS)	Median time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours (RECIST v1.1): >= 20% increase in the sum of diameters of Target Lesions (TL) and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of Non TLs or a new lesion.	Baseline and then every 6 weeks after randomization until objective disease progression, up to 29 months (at the time of the analysis)

Measure	Description	Time Frame
Overall Survival (OS)	The time from randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive	Following progression, survival status was collected every 8 weeks until death, withdrawal of consent, or end of study, whichever occurred first, up to 29 months (at the time of the analysis)

Name	Affiliation	Role
Gabriella Mariani, MD	AstraZeneca UK, MSD	Study Chair
Pasi Janne, MD	Dana-Farber Cancer Institute, USA	Principal Investigator
Jean-Charles Soria, MD	Institut de Cancerology Gustave Roussy, France	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Santa Monica	California	90404	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
29045535	Derived	Soria JC, Fulop A, Maciel C, Fischer JR, Girotto G, Lago S, Smit E, Ostoros G, Eberhardt WEE, Lishkovska P, Lovick S, Mariani G, McKeown A, Kilgour E, Smith P, Bowen K, Kohlmann A, Carlile DJ, Janne PA. SELECT-2: a phase II, double-blind, randomized, placebo-controlled study to assess the efficacy of selumetinib plus docetaxel as a second-line treatment of patients with advanced or metastatic non-small-cell lung cancer. Ann Oncol. 2017 Dec 1;28(12):3028-3036. doi: 10.1093/annonc/mdx628.

Label	URL
CSR Synopsis Redacted	View source

ID	Title	Description
FG000	Placebo + Docetaxel 75 mg/m^2	Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
FG001	Selumetinib 75 mg BD + Docetaxel 60 mg/m^2	Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected43 at risk EG0011 events1 affected84 at risk EG0024 events4 affected84 at risk
Cardiac arrest	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Chronic right ventricular failure	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Left ventricular failure	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0022 events2 affected84 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Glossitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Ileus	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0023 events2 affected84 at risk
Asthenia	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Fatigue	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
Generalised oedema	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
Oedema peripheral	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Performance status decreased	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Pyrexia	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Cellulitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Erysipelas	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Lung infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG00113 events10 affected84 at risk EG0024 events4 affected84 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Sepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0024 events4 affected84 at risk
Septic shock	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Chemical peritonitis	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Alanine aminotransferase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Blood creatine phosphokinase MB increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Blood creatinine increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Blood urea increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0022 events2 affected84 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Dizziness	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Embolic stroke	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Seizure	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Syncope	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Renal failure	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0015 events4 affected84 at risk EG0024 events4 affected84 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0023 events3 affected84 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Aortic thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Hypotension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected43 at risk EG00122 events20 affected84 at risk EG00221 events18 affected84 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0024 events3 affected84 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0012 events2 affected84 at risk EG0020 events0 affected84 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0003 events2 affected43 at risk EG0012 events2 affected84 at risk EG0023 events3 affected84 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG00012 events10 affected43 at risk EG00126 events9 affected84 at risk EG00219 events17 affected84 at risk
Neutrophilia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0012 events2 affected84 at risk EG0023 events2 affected84 at risk
Arrhythmia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0013 events3 affected84 at risk EG0024 events3 affected84 at risk
Atrial flutter	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Bundle branch block left	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Nodal rhythm	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Palpitations	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Pericarditis	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Right ventricular failure	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0022 events2 affected84 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Tachycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events2 affected84 at risk EG0021 events1 affected84 at risk
Deafness	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Middle ear inflammation	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0012 events2 affected84 at risk EG0021 events1 affected84 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Blepharitis	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Chorioretinal disorder	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Dry eye	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0023 events3 affected84 at risk
Eye discharge	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Eye disorder	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
Eye irritation	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Eye oedema	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Eye pain	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Eye swelling	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Eyelid oedema	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0025 events2 affected84 at risk
Eyelid pain	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Lacrimation increased	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0012 events2 affected84 at risk EG0027 events7 affected84 at risk
Noninfective conjunctivitis	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Periorbital oedema	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0024 events3 affected84 at risk
Vision blurred	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0014 events4 affected84 at risk EG0023 events3 affected84 at risk
Visual acuity reduced	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Visual impairment	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events2 affected84 at risk EG0020 events0 affected84 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0013 events2 affected84 at risk EG0021 events1 affected84 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0004 events3 affected43 at risk EG00112 events9 affected84 at risk EG0026 events6 affected84 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0005 events4 affected43 at risk EG0013 events3 affected84 at risk EG0029 events8 affected84 at risk
Abdominal rigidity	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0022 events1 affected84 at risk
Breath odour	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Buccal mucosal roughening	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Chapped lips	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected43 at risk EG00118 events16 affected84 at risk EG00213 events11 affected84 at risk
Dental cyst	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00021 events12 affected43 at risk EG00178 events41 affected84 at risk EG00265 events37 affected84 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0013 events3 affected84 at risk EG0024 events4 affected84 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00010 events4 affected43 at risk EG0016 events6 affected84 at risk EG0024 events4 affected84 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0024 events4 affected84 at risk
Eructation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Flatulence	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0022 events2 affected84 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Gastritis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0026 events6 affected84 at risk
Glossitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Hyperchlorhydria	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events1 affected84 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Lip erosion	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0024 events4 affected84 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00022 events10 affected43 at risk EG00133 events25 affected84 at risk EG00236 events23 affected84 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Oral mucosal eruption	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Oral pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Steatorrhoea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events1 affected84 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0007 events5 affected43 at risk EG00111 events11 affected84 at risk EG00233 events23 affected84 at risk
Tooth loss	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Toothache	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events1 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00013 events8 affected43 at risk EG00128 events20 affected84 at risk EG00227 events22 affected84 at risk
Asthenia	General disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG00112 events12 affected84 at risk EG00214 events13 affected84 at risk
Catheter site related reaction	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Chest discomfort	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Chest pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Chills	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
Extravasation	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Face oedema	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0014 events4 affected84 at risk EG0024 events4 affected84 at risk
Fatigue	General disorders	MedDRA 18.1	Systematic Assessment	EG00017 events13 affected43 at risk EG00121 events17 affected84 at risk EG00232 events26 affected84 at risk
General physical health deterioration	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0022 events2 affected84 at risk
Generalised oedema	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0023 events3 affected84 at risk
Hyperthermia	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Influenza like illness	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0012 events2 affected84 at risk EG0023 events3 affected84 at risk
Malaise	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Mucosal inflammation	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0028 events7 affected84 at risk
Non-cardiac chest pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Oedema	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0024 events4 affected84 at risk
Oedema peripheral	General disorders	MedDRA 18.1	Systematic Assessment	EG00010 events8 affected43 at risk EG00122 events16 affected84 at risk EG00238 events28 affected84 at risk
Pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Performance status decreased	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Pyrexia	General disorders	MedDRA 18.1	Systematic Assessment	EG0005 events3 affected43 at risk EG00115 events11 affected84 at risk EG00220 events11 affected84 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Angular cheilitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0022 events2 affected84 at risk
Bronchitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0012 events2 affected84 at risk EG0026 events6 affected84 at risk
Candida infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Cellulitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Clostridium colitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Conjunctivitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0025 events5 affected84 at risk
Diverticulitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Ear infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events2 affected84 at risk EG0020 events0 affected84 at risk
Erysipelas	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Folliculitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0012 events2 affected84 at risk EG0022 events2 affected84 at risk
Fungal skin infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events1 affected84 at risk EG0020 events0 affected84 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Gingivitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Laryngitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Lung infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0014 events4 affected84 at risk EG0022 events2 affected84 at risk
Mastitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected43 at risk EG0015 events4 affected84 at risk EG0021 events1 affected84 at risk
Nosocomial infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Oral candidiasis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0004 events3 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Oral fungal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0015 events4 affected84 at risk EG0022 events1 affected84 at risk
Oral infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Paronychia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0029 events7 affected84 at risk
Peritonitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Pharyngitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0014 events4 affected84 at risk EG0023 events3 affected84 at risk
Rash pustular	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0027 events5 affected84 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Respiratory tract infection bacterial	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Rhinitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0011 events1 affected84 at risk EG0023 events3 affected84 at risk
Septic shock	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Skin infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
Staphylococcal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0017 events5 affected84 at risk EG0021 events1 affected84 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Wound infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0024 events3 affected84 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0012 events2 affected84 at risk EG0021 events1 affected84 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Alanine aminotransferase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0014 events4 affected84 at risk EG0020 events0 affected84 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0014 events4 affected84 at risk EG0022 events2 affected84 at risk
Blood calcium decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Blood creatine phosphokinase MB increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG00111 events3 affected84 at risk EG00211 events5 affected84 at risk
Blood creatinine increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Blood magnesium decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events2 affected84 at risk EG0020 events0 affected84 at risk
Blood pressure systolic increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Blood sodium decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Blood triglycerides increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Breath sounds abnormal	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
C-reactive protein increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0022 events1 affected84 at risk
Ejection fraction decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0014 events4 affected84 at risk EG0022 events2 affected84 at risk
Haemoglobin decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Hepatic enzyme abnormal	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Hepatic enzyme increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
International normalised ratio increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Intraocular pressure increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Platelet count decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Prothrombin time prolonged	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Weight decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected43 at risk EG0013 events3 affected84 at risk EG0026 events6 affected84 at risk
Weight increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
White blood cell count decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Central obesity	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG00010 events10 affected43 at risk EG00121 events21 affected84 at risk EG00220 events18 affected84 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0014 events4 affected84 at risk EG0024 events4 affected84 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events1 affected84 at risk EG0020 events0 affected84 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0023 events2 affected84 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0003 events2 affected43 at risk EG0013 events3 affected84 at risk EG0023 events2 affected84 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0015 events5 affected84 at risk EG0022 events2 affected84 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected43 at risk EG0014 events3 affected84 at risk EG0023 events2 affected84 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0024 events4 affected84 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Vitamin K deficiency	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events2 affected84 at risk EG0020 events0 affected84 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0017 events6 affected84 at risk EG0025 events4 affected84 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected43 at risk EG0013 events3 affected84 at risk EG0027 events7 affected84 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0010 events0 affected84 at risk EG0023 events3 affected84 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0017 events4 affected84 at risk EG0023 events3 affected84 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected43 at risk EG0016 events6 affected84 at risk EG00210 events9 affected84 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0024 events4 affected84 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0007 events6 affected43 at risk EG0015 events4 affected84 at risk EG0022 events2 affected84 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0023 events3 affected84 at risk
Oncologic complication	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0014 events4 affected84 at risk EG0022 events2 affected84 at risk
Ageusia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Amnesia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Ataxia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Dizziness	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0007 events7 affected43 at risk EG0015 events5 affected84 at risk EG0025 events5 affected84 at risk
Dizziness postural	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Dysaesthesia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Dysarthria	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Dysgeusia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected43 at risk EG0016 events6 affected84 at risk EG0028 events8 affected84 at risk
Head discomfort	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Headache	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected43 at risk EG0016 events6 affected84 at risk EG0023 events3 affected84 at risk
Hemiparesis	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Hypokinesia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Hypotonia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Lethargy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
Memory impairment	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0024 events4 affected84 at risk
Paraesthesia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0014 events3 affected84 at risk EG0023 events3 affected84 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0014 events4 affected84 at risk EG0024 events4 affected84 at risk
Polyneuropathy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0014 events4 affected84 at risk EG0024 events3 affected84 at risk
Somnolence	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Syncope	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events2 affected84 at risk EG0020 events0 affected84 at risk
Tremor	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Anxiety	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0013 events3 affected84 at risk EG0021 events1 affected84 at risk
Delirium	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Depression	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Disorientation	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Insomnia	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0015 events4 affected84 at risk EG0023 events3 affected84 at risk
Sleep disorder	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0003 events2 affected43 at risk EG0010 events0 affected84 at risk EG0022 events1 affected84 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Bladder pain	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events1 affected84 at risk
Costovertebral angle tenderness	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Dysuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0026 events5 affected84 at risk
Oliguria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Proteinuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Renal cyst	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Renal failure	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0022 events2 affected84 at risk
Renal impairment	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Renal infarct	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Renal vein thrombosis	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Urinary retention	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0022 events1 affected84 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events1 affected84 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0013 events3 affected84 at risk EG0020 events0 affected84 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0008 events8 affected43 at risk EG0017 events7 affected84 at risk EG00210 events10 affected84 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events2 affected84 at risk EG0021 events1 affected84 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected43 at risk EG00112 events12 affected84 at risk EG00215 events14 affected84 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0013 events3 affected84 at risk EG0024 events4 affected84 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0003 events2 affected43 at risk EG0016 events6 affected84 at risk EG0029 events8 affected84 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0011 events1 affected84 at risk EG0028 events7 affected84 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Nasal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0013 events3 affected84 at risk EG0025 events5 affected84 at risk
Pharyngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0013 events3 affected84 at risk EG0023 events3 affected84 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0022 events1 affected84 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events1 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0008 events8 affected43 at risk EG00111 events11 affected84 at risk EG00216 events15 affected84 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG00118 events9 affected84 at risk EG0029 events7 affected84 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG00110 events9 affected84 at risk EG00216 events16 affected84 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0015 events4 affected84 at risk EG0026 events5 affected84 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events2 affected84 at risk EG0020 events0 affected84 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Madarosis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0023 events3 affected84 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0013 events3 affected84 at risk EG0021 events1 affected84 at risk
Nail growth abnormal	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Nail ridging	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Onychalgia	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events1 affected84 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected84 at risk EG0022 events2 affected84 at risk
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected84 at risk EG0022 events2 affected84 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events2 affected84 at risk EG0023 events2 affected84 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0015 events4 affected84 at risk EG0024 events4 affected84 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG00010 events9 affected43 at risk EG00126 events23 affected84 at risk EG00244 events29 affected84 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0013 events2 affected84 at risk EG0020 events0 affected84 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0023 events3 affected84 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0022 events2 affected84 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events2 affected84 at risk EG0020 events0 affected84 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0012 events1 affected84 at risk EG0020 events0 affected84 at risk
Xeroderma	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Circulatory collapse	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Embolism	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Flushing	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Hot flush	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0010 events0 affected84 at risk EG0020 events0 affected84 at risk
Hypertension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0004 events3 affected43 at risk EG0012 events2 affected84 at risk EG00211 events10 affected84 at risk
Hypotension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0011 events1 affected84 at risk EG0022 events2 affected84 at risk
Lymphoedema	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0022 events2 affected84 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected84 at risk EG0021 events1 affected84 at risk
Peripheral coldness	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Phlebitis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0020 events0 affected84 at risk
Thrombophlebitis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected84 at risk EG0021 events1 affected84 at risk

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D009362	Neoplasm Metastasis

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	Placebo + Docetaxel 75 mg/m^2	Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle
BG001	Selumetinib 75 mg BD + Docetaxel 60 mg/m^2	Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
BG002	Selumetinib 75 mg BD + Docetaxel 75 mg/m^2	Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo + Docetaxel 75 mg/m^2	Oral placebo BD and intravenous docetaxel on day 1 of every 21 day cycle	16	43	38	43
EG001	Selumetinib 75 mg BD + Docetaxel 60 mg/m^2	Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle	40	84	80	84
EG002	Selumetinib 75 mg BD + Docetaxel 75 mg/m^2	Oral selumetinib BD and intravenous docetaxel on day 1 of every 21 day cycle	38	84	83	84