Assess Efficacy & Safety of Selumetinib in Combination Wi... | NCT01933932

ID	Type	Description	Link
2013-001676-38	EudraCT Number

Label	Type	Description	Intervention Names
Selumetinib + Docetaxel	Experimental	Three 25mg 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 Drug: Docetaxel Drug: Pegylated G-CSF
Placebo + Docetaxel	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 Drug: Placebo Drug: Pegylated G-CSF

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

Measure	Description	Time Frame
Progression-Free Survival (PFS)	Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)	Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

Measure	Description	Time Frame
Overall Survival (OS)	Overall Survival is defined as the time from the date of randomisation until death due to any cause.	Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI
Objective Response Rate (ORR)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provision of signed, written and dated informed consent prior to any study specific procedures
Male or female, aged 18 years or older
Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
KRAS mutation positive tumour sample as determined by the designated testing laboratory
Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy

Exclusion Criteria:

Mixed small cell and non-small cell lung cancer histology.
Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
Other concomitant anti-cancer therapy agents excepts steroids
Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment

Name	Affiliation	Role
Gabriella Mariani, MD	AstraZeneca UK, MSD	Study Chair
Pasi Jänne, MD	Dana-Faber Cancer Institute, USA	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aurora	Colorado	80045	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
28492898	Derived	Janne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crino L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J. Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer: The SELECT-1 Randomized Clinical Trial. JAMA. 2017 May 9;317(18):1844-1853. doi: 10.1001/jama.2017.3438.
26837474

Label	URL
CSP\_redacted	View source

ID	Title	Description
FG000	Selumetinib + Docetaxel	Three 25mg 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
FG001	Placebo + Docetaxel

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-Free Survival (PFS)

Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)

Full analysis set (FAS) population comprised of all randomised patients.

Posted

Median

Inter-Quartile Range

Months

Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

ID	Title	Description
OG000	Selumetinib + Docetaxel	Three 25mg 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
OG001	Placebo + Docetaxel	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.

Units	Counts
Participants	OG000254 OG001256

Title

Denominators

Categories

Title	Measurements
	OG0003.9(1.5 to 5.9) OG0012.8(1.4 to 5.5)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Analysis stratified by WHO performance status at randomisation.	0.4355		Hazard Ratio (HR)	0.93			2-Sided	95	0.77	1.12					Superiority or Other (legacy)

Secondary

Overall Survival (OS)

Overall Survival is defined as the time from the date of randomisation until death due to any cause.

Full analysis set (FAS) population comprised of all randomised patients.

Posted

Median

Inter-Quartile Range

Months

Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI

ID	Title	Description
OG000	Selumetinib + Docetaxel	Three 25mg 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
OG001	Placebo + Docetaxel	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.

Units	Counts
Participants	OG000

Secondary

Objective Response Rate (ORR)

ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - >=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result)

Full analysis set (FAS) population comprised of all randomised patients.

Posted

Number

Number of responders

Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

ID	Title	Description
OG000	Selumetinib + Docetaxel	Three 25mg 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
OG001	Placebo + Docetaxel	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.

Units	Counts

Secondary

Duration of Response (DoR)

Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)

Full analysis set (FAS) population comprised of all randomised patients.

Posted

Median

95% Confidence Interval

Days

Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

ID	Title	Description
OG000	Selumetinib + Docetaxel	Three 25mg 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
OG001	Placebo + Docetaxel	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.

Units	Counts
Participants

Secondary

Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)

The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline ≥10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.

Full analysis set (FAS) patients who have a baseline ASBI score >= 10

Posted

Number

Number of patients with improvements

Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)

ID	Title	Description
OG000	Selumetinib + Docetaxel	Three 25mg 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
OG001	Placebo + Docetaxel	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.

Secondary

Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)

Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline ≥10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.

Full analysis set (FAS) patients who have a baseline ASBI score <= 90

Posted

Median

Inter-Quartile Range

Months

ID	Title	Description
OG000	Selumetinib + Docetaxel	Three 25mg 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
OG001	Placebo + Docetaxel	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.

Units

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG0013 events3 affected251 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0014 events4 affected251 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0015 events5 affected251 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events3 affected251 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Coronary artery dissection	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Pericardial effusion	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Pericarditis constrictive	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Retinal vein thrombosis	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0012 events2 affected251 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Colitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG00110 events10 affected251 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Proctitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Subileus	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0013 events3 affected251 at risk
Asthenia	General disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Euthanasia	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Fatigue	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
General physical health deterioration	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events3 affected251 at risk
Malaise	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Oedema peripheral	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Pyrexia	General disorders	MedDRA 18.1	Systematic Assessment	EG0009 events5 affected254 at risk EG0018 events7 affected251 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Anaphylactic shock	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Hypersensitivity	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Anal abscess	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Arthritis infective	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Bronchitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Device related infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Diverticulitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Herpes zoster	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Infected skin ulcer	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events1 affected251 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected254 at risk EG0014 events4 affected251 at risk
Lung abscess	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Lung infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0013 events3 affected251 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG00014 events11 affected254 at risk EG00120 events17 affected251 at risk
Pneumonia viral	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0003 events2 affected254 at risk EG0016 events6 affected251 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Sepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0017 events7 affected251 at risk
Staphylococcal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Urosepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
C-reactive protein increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events2 affected251 at risk
Ejection fraction decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0016 events6 affected251 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0010 events0 affected251 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Cognitive disorder	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Dropped head syndrome	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Neurological decompensation	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events1 affected251 at risk
Polyneuropathy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Somnolence	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Syncope	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events2 affected251 at risk
Confusional state	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Neurogenic bladder	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0005 events4 affected254 at risk EG0017 events7 affected251 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0014 events4 affected251 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0005 events3 affected254 at risk EG0011 events1 affected251 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0013 events3 affected251 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0014 events4 affected251 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Hypotension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Internal haemorrhage	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Venous thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 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	EG00040 events37 affected254 at risk EG00150 events46 affected251 at risk
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG0017 events7 affected251 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG0017 events5 affected251 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG00015 events14 affected254 at risk EG00124 events22 affected251 at risk
Neutrophilia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0004 events3 affected254 at risk EG0011 events1 affected251 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG0015 events5 affected251 at risk
Bradycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Bundle branch block left	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0015 events5 affected251 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Cardiomegaly	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Palpitations	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Pericardial effusion	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0010 events0 affected251 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0004 events3 affected254 at risk EG0010 events0 affected251 at risk
Tachycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0008 events7 affected254 at risk EG0014 events4 affected251 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Deafness	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0006 events6 affected254 at risk EG0018 events8 affected251 at risk
Goitre	Endocrine disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Oestrogen deficiency	Endocrine disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Cataract	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Chorioretinopathy	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Conjunctival irritation	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Diplopia	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Dry eye	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0014 events4 affected251 at risk
Eye discharge	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Eye irritation	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0013 events3 affected251 at risk
Eye pain	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Eyelid oedema	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG00110 events10 affected251 at risk
Eyelid skin dryness	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Hypermetropia	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Keratitis	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Lacrimation increased	Eye disorders	MedDRA 18.1	Systematic Assessment	EG00013 events13 affected254 at risk EG00116 events16 affected251 at risk
Macular oedema	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Ocular discomfort	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Ocular hyperaemia	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Ocular icterus	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Optic nerve compression	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Periorbital oedema	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG00111 events11 affected251 at risk
Photopsia	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Presbyopia	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Retinal vascular disorder	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Retinal vein thrombosis	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Retinopathy	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Ulcerative keratitis	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Vision blurred	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG0018 events8 affected251 at risk
Visual acuity reduced	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0013 events3 affected251 at risk
Visual impairment	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0013 events3 affected251 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0013 events3 affected251 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0013 events3 affected251 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00025 events19 affected254 at risk EG00125 events23 affected251 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00012 events11 affected254 at risk EG00113 events12 affected251 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events3 affected251 at risk
Anal inflammation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Ascites	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Colitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00057 events47 affected254 at risk EG00143 events39 affected251 at risk
Defaecation urgency	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Dental caries	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG000126 events86 affected254 at risk EG001234 events149 affected251 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG00116 events15 affected251 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00014 events12 affected254 at risk EG00114 events14 affected251 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0006 events5 affected254 at risk EG0018 events8 affected251 at risk
Enteritis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Eructation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Flatulence	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0012 events2 affected251 at risk
Gastritis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0012 events2 affected251 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0003 events2 affected254 at risk EG0018 events8 affected251 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0003 events2 affected254 at risk EG0011 events1 affected251 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0013 events3 affected251 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Hyperchlorhydria	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Lip blister	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Lip dry	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Melaena	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0014 events4 affected251 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00081 events62 affected254 at risk EG001117 events94 affected251 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Oesophageal pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Oral discomfort	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Oral dysaesthesia	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Oral pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0013 events3 affected251 at risk
Rectal tenesmus	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00038 events33 affected254 at risk EG00182 events65 affected251 at risk
Swollen tongue	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Tooth loss	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Toothache	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0011 events1 affected251 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG00040 events31 affected254 at risk EG00187 events64 affected251 at risk
Asthenia	General disorders	MedDRA 18.1	Systematic Assessment	EG00054 events46 affected254 at risk EG00176 events66 affected251 at risk
Catheter site inflammation	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Chest pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events3 affected251 at risk
Chills	General disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0016 events6 affected251 at risk
Device failure	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Extravasation	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Face oedema	General disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG00126 events22 affected251 at risk
Fatigue	General disorders	MedDRA 18.1	Systematic Assessment	EG00096 events78 affected254 at risk EG00197 events69 affected251 at risk
Feeling cold	General disorders	MedDRA 18.1	Systematic Assessment	EG0002 events1 affected254 at risk EG0011 events1 affected251 at risk
Feeling hot	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Gait disturbance	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
General physical health deterioration	General disorders	MedDRA 18.1	Systematic Assessment	EG0004 events3 affected254 at risk EG0010 events0 affected251 at risk
Generalised oedema	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0018 events8 affected251 at risk
Hyperthermia	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Inflammation	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Inflammatory pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Influenza like illness	General disorders	MedDRA 18.1	Systematic Assessment	EG00010 events9 affected254 at risk EG0012 events2 affected251 at risk
Infusion site extravasation	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Injection site pruritus	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Injection site reaction	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Local swelling	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Localised oedema	General disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Malaise	General disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG0011 events1 affected251 at risk
Mucosal inflammation	General disorders	MedDRA 18.1	Systematic Assessment	EG0003 events2 affected254 at risk EG00110 events9 affected251 at risk
Mucosal toxicity	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Nodule	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Non-cardiac chest pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0006 events5 affected254 at risk EG0017 events7 affected251 at risk
Oedema	General disorders	MedDRA 18.1	Systematic Assessment	EG0007 events7 affected254 at risk EG00114 events13 affected251 at risk
Oedema peripheral	General disorders	MedDRA 18.1	Systematic Assessment	EG00040 events38 affected254 at risk EG00198 events75 affected251 at risk
Pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG00110 events9 affected251 at risk
Performance status decreased	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Peripheral swelling	General disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0019 events6 affected251 at risk
Pyrexia	General disorders	MedDRA 18.1	Systematic Assessment	EG00042 events31 affected254 at risk EG00162 events47 affected251 at risk
Soft tissue inflammation	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Temperature intolerance	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Tenderness	General disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Xerosis	General disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0012 events2 affected251 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events3 affected251 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events1 affected251 at risk
Jaundice	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Contrast media allergy	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Iodine allergy	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Abdominal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Anal abscess	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Anal fungal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Anal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Angular cheilitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Aspergillus infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Bacterial infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Bacteriuria	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Breast abscess	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Bronchitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0008 events7 affected254 at risk EG0019 events8 affected251 at risk
Bullous impetigo	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Candida infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events3 affected251 at risk
Cellulitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events3 affected251 at risk
Clostridial infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Conjunctivitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0007 events5 affected254 at risk EG00113 events12 affected251 at risk
Cystitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0006 events6 affected254 at risk EG0014 events3 affected251 at risk
Device related infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Diverticulitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Ear infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Erysipelas	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Eye infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Folliculitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0016 events4 affected251 at risk
Fungal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG0011 events1 affected251 at risk
Fungal oesophagitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Fungal skin infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Genital infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Gingivitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Helicobacter infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Herpes simplex	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Herpes virus infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Herpes zoster	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Hordeolum	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Impetigo	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Infected dermal cyst	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Influenza	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0013 events3 affected251 at risk
Injection site infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Localised infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0007 events7 affected254 at risk EG0011 events1 affected251 at risk
Lung infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0006 events5 affected254 at risk EG0015 events5 affected251 at risk
Mucosal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0008 events7 affected254 at risk EG00112 events10 affected251 at risk
Onychomycosis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Oral candidiasis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected254 at risk EG0015 events5 affected251 at risk
Oral fungal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0014 events4 affected251 at risk
Oral herpes	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0014 events3 affected251 at risk
Oral infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Oropharyngeal candidiasis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Oropharyngitis fungal	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Otitis externa	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Otitis media	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Paronychia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0006 events6 affected254 at risk EG00114 events14 affected251 at risk
Pharyngitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG00111 events8 affected251 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Rash pustular	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0018 events6 affected251 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG00010 events8 affected254 at risk EG00110 events9 affected251 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Rhinitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Sepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Sialoadenitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Sinusitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected254 at risk EG0017 events6 affected251 at risk
Skin candida	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Skin infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG0011 events1 affected251 at risk
Staphylococcal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events1 affected251 at risk
Tonsillitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Tonsillitis bacterial	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Tooth abscess	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0012 events1 affected251 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG00011 events8 affected254 at risk EG0011 events1 affected251 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG00011 events6 affected254 at risk EG00121 events16 affected251 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Urosepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Vaginal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Viral infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Viral pharyngitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Epiphyseal fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0014 events4 affected251 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG0010 events0 affected251 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0003 events2 affected254 at risk EG0011 events1 affected251 at risk
Procedural site reaction	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Pulmonary radiation injury	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Skin wound	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Venous injury	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Alanine aminotransferase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected254 at risk EG0018 events6 affected251 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0017 events6 affected251 at risk
Blood albumin decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG0011 events1 affected251 at risk
Blood bilirubin increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Blood calcium increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Blood creatine phosphokinase MB increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0016 events1 affected251 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0019 events6 affected251 at risk
Blood creatinine increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG00110 events6 affected251 at risk
Blood glucose increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Blood potassium decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Blood pressure decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Blood pressure increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Blood pressure systolic decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Blood thyroid stimulating hormone decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Blood urea increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Body temperature increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Breath sounds abnormal	Investigations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
C-reactive protein increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0019 events7 affected251 at risk
Carcinoembryonic antigen increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Eastern Cooperative Oncology Group performance status worsened	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Ejection fraction decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0015 events5 affected251 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0006 events6 affected254 at risk EG0016 events6 affected251 at risk
Inspiratory capacity decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
International normalised ratio increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Neutrophil count decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0002 events1 affected254 at risk EG0011 events1 affected251 at risk
Neutrophil count increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Oxygen saturation decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Platelet count decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0014 events3 affected251 at risk
Platelet count increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Protein total decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Transaminases increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Troponin I increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events1 affected251 at risk
Troponin increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Urine output decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Weight decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG00012 events11 affected254 at risk EG00121 events21 affected251 at risk
Weight increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0017 events7 affected251 at risk
White blood cell count increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG00076 events60 affected254 at risk EG00168 events56 affected251 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0006 events6 affected254 at risk EG00112 events11 affected251 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0014 events2 affected251 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Hyperproteinaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG00111 events9 affected251 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0015 events5 affected251 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events1 affected251 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG00111 events11 affected251 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG00010 events6 affected254 at risk EG0013 events3 affected251 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG00111 events11 affected251 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0014 events2 affected251 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0010 events0 affected251 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Magnesium deficiency	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Amyotrophy	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG00023 events19 affected254 at risk EG00124 events23 affected251 at risk
Axillary mass	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG00032 events28 affected254 at risk EG00122 events19 affected251 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG00021 events20 affected254 at risk EG00123 events18 affected251 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Fistula discharge	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Fracture pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Hypercreatinaemia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0008 events7 affected254 at risk EG0013 events3 affected251 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0008 events7 affected254 at risk EG00110 events10 affected251 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG00012 events12 affected254 at risk EG00111 events11 affected251 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG00015 events13 affected254 at risk EG0015 events5 affected251 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG00049 events37 affected254 at risk EG00124 events23 affected251 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0006 events5 affected254 at risk EG0014 events4 affected251 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG00020 events15 affected254 at risk EG00111 events9 affected251 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Rheumatic disorder	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Endometrial sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Tumour necrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Ageusia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0003 events2 affected254 at risk EG0011 events1 affected251 at risk
Amnesia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Aphasia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Aphonia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Apraxia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Balance disorder	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Burning sensation	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Cerebellar syndrome	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Coordination abnormal	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Disturbance in attention	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events3 affected251 at risk
Dizziness	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG00011 events10 affected254 at risk EG00115 events15 affected251 at risk
Dizziness postural	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Dysarthria	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Dysgeusia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG00025 events23 affected254 at risk EG00117 events17 affected251 at risk
Extrapyramidal disorder	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Facial neuralgia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Headache	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG00030 events26 affected254 at risk EG00110 events9 affected251 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Hypersomnia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0005 events3 affected254 at risk EG0011 events1 affected251 at risk
Lethargy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected254 at risk EG0011 events1 affected251 at risk
Memory impairment	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Monoparesis	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Neuralgia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected254 at risk EG0010 events0 affected251 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG00010 events10 affected254 at risk EG00112 events12 affected251 at risk
Neurotoxicity	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Paraesthesia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG00023 events17 affected254 at risk EG00118 events18 affected251 at risk
Paresis	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Parosmia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Partial seizures	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0009 events7 affected254 at risk EG0019 events9 affected251 at risk
Polyneuropathy	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected254 at risk EG0014 events4 affected251 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Sciatica	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Seizure	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Somnolence	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Syncope	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0017 events6 affected251 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Agitation	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Anxiety	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected254 at risk EG00110 events10 affected251 at risk
Confusional state	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0016 events5 affected251 at risk
Delusion	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Depression	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG0014 events4 affected251 at risk
Disorientation	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Hallucination	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Illusion	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Insomnia	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG00011 events10 affected254 at risk EG0019 events9 affected251 at risk
Irritability	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Panic attack	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Sleep disorder	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Stress	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Tension	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Chromaturia	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events1 affected251 at risk
Costovertebral angle tenderness	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Cystitis noninfective	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Dysuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0014 events4 affected251 at risk
Haematuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Haemoglobinuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Proteinuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0013 events2 affected251 at risk
Renal failure	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Strangury	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Urinary retention	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0013 events3 affected251 at risk
Urinary tract pain	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Urine odour abnormal	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Acquired hydrocele	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Breast discomfort	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Polymenorrhoea	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Prostatism	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events1 affected251 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG00044 events35 affected254 at risk EG00139 events37 affected251 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0007 events7 affected254 at risk EG00112 events11 affected251 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG00041 events40 affected254 at risk EG00157 events55 affected251 at risk
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0007 events7 affected254 at risk EG0016 events6 affected251 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG00010 events8 affected254 at risk EG00113 events13 affected251 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG00014 events8 affected254 at risk EG00112 events8 affected251 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0013 events3 affected251 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0012 events2 affected251 at risk
Increased bronchial secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG0012 events2 affected251 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0008 events8 affected254 at risk EG0018 events7 affected251 at risk
Pleural disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG00012 events9 affected254 at risk EG00114 events11 affected251 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG00011 events10 affected254 at risk EG0018 events8 affected251 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0013 events3 affected251 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Pulmonary pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0012 events2 affected251 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0007 events6 affected254 at risk EG0015 events5 affected251 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0017 events7 affected251 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG00065 events64 affected254 at risk EG00149 events49 affected251 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG00134 events30 affected251 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG00019 events14 affected254 at risk EG00131 events30 affected251 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events2 affected251 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0008 events8 affected254 at risk EG0017 events7 affected251 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0014 events4 affected251 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Hand dermatitis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG0012 events2 affected251 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Hypertrichosis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Nail bed disorder	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Nail bed inflammation	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected254 at risk EG0018 events8 affected251 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Nail ridging	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Nail toxicity	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0003 events2 affected254 at risk EG0010 events0 affected251 at risk
Onychalgia	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected254 at risk EG0014 events4 affected251 at risk
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0007 events7 affected254 at risk EG00112 events12 affected251 at risk
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events3 affected251 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0017 events7 affected251 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0010 events0 affected251 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG00012 events12 affected254 at risk EG00121 events16 affected251 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events2 affected251 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0011 events1 affected251 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG00029 events28 affected254 at risk EG001114 events85 affected251 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG00110 events7 affected251 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0014 events4 affected251 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG00110 events7 affected251 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0019 events8 affected251 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Scar pain	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0004 events3 affected254 at risk EG0012 events2 affected251 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0015 events5 affected251 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Skin plaque	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events2 affected251 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Solar dermatitis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0013 events3 affected251 at risk
Telangiectasia	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0012 events2 affected251 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0012 events2 affected251 at risk
Embolism	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Flushing	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected254 at risk EG0013 events3 affected251 at risk
Haematoma	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0004 events4 affected254 at risk EG0012 events2 affected251 at risk
Haemorrhage	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Hot flush	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0005 events5 affected254 at risk EG0010 events0 affected251 at risk
Hypertension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0005 events3 affected254 at risk EG0015 events4 affected251 at risk
Hypotension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0008 events8 affected254 at risk EG00116 events13 affected251 at risk
Inferior vena cava syndrome	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Lymphoedema	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0012 events2 affected251 at risk
Peripheral coldness	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0011 events1 affected251 at risk
Phlebitis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected254 at risk EG0010 events0 affected251 at risk
Varicose vein	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected254 at risk EG0011 events1 affected251 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
C517975	AZD 6244
D000077143	Docetaxel
C455861	pegfilgrastim

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	Selumetinib + Docetaxel	Three 25mg 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
BG001	Placebo + Docetaxel	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo + Docetaxel	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.			82	254	235	254
EG001	Selumetinib + Docetaxel	Three 25mg 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			124	251	244	251