Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Contin... | NCT00267748

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
C	Experimental		Drug: Sunitinib Malate Continuous Daily Dosing
A	Experimental		Drug: Sunitinib Malate Schedule 4/2

Name	Type	Description	Arm Group Labels	Other Names
Sunitinib Malate Continuous Daily Dosing	Drug	Sunitinib malate starting dose 37.5 mg daily continuous daily regimen.	C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model	MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=>3) based on number of criteria present such as Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal,Hemoglobin < lower limit of normal, serum calcium > 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.	From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Objective Response (OR)	Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Other Outcomes

Measure	Description	Time Frame
Functional Assessment of Cancer Therapy-General (FACT-G)	FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states.

Eligibility Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Hot Springs	Arkansas	71913	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28410911	Derived	de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
27238653	Derived

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Sunitinib 37.5 mg + Interferon Alpha-2b	Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Sunitinib 37.5 mg + Interferon Alpha-2b	Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
BG001	Sunitinib 50 mg (Schedule 4/2)	Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
BG002	Sunitinib 37.5 mg	Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
BG003	Total	Total of all reporting groups

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

Time to Tumor Progression (TTP) Assessed Using Memorial Sloan-Kettering Cancer Center (MSKCC) Prognostic Factors Model

MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=>3) based on number of criteria present such as Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal,Hemoglobin < lower limit of normal, serum calcium > 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.

The intent-to-treat (ITT) population included all participants who were randomized into the study regardless of whether they received study medication.

Posted

Median

95% Confidence Interval

Months

From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

ID	Title	Description
OG000	Sunitinib 50 mg (Schedule 4/2)	Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
OG001	Sunitinib 37.5 mg	Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.

Units	Counts
Participants	OG000146 OG001146

Title

Denominators

Categories

Stratified analysis : High Risk (=>3)

Title	Measurements
	OG0003.1(0.5 to 10.4) OG0014.4(1.4 to 7.1)

Stratified analysis : Intermediate Risk (1-2)

Title	Measurements
	OG000

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	For High risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.	Log Rank		0.860		Hazard Ratio (HR)	1.089			2-Sided	95	0.423	2.803				No	Superiority or Other

Secondary

Percentage of Participants With Objective Response (OR)

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with atleast 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

ITT population included all participants who were randomized into the study regardless of whether they received study medication.

Posted

Number

95% Confidence Interval

Percentage of participants

From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

ID	Title	Description
OG000	Sunitinib 50 mg (Schedule 4/2)	Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
OG001	Sunitinib 37.5 mg	Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.

Secondary

Duration of Response (DR)

Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

DR was calculated for the subgroup of participants from the ITT set, with a confirmed OR.

Posted

Median

Full Range

Months

From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

ID	Title	Description
OG000	Sunitinib 50 mg (Schedule 4/2)	Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
OG001	Sunitinib 37.5 mg	Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.

Units	Counts
Participants

Secondary

Overall Survival (OS) Assessed Using MSKCC Prognostic Factors Model

MSKCC Prognostic Factor Model assessed as low (0), intermediate (1-2) or high (=>3) based upon number of criteria present. Criteria as follows: Karnofsky performance status < 80 %, Lactate dehydrogenase > 1.5 * Upper limit of Normal, Hemoglobin < lower limit of normal for local lab, Corrected serum calcium > 10 mg/dL; Time from first diagnosis of renal cell carcinoma to start of systemic therapy of < 1 year. OS was defined as time from date of start of treatment to date of death due to any cause. OS, in months, was calculated as (event date -start of treatment date + 1)/30.44.

ITT population included all participants who were randomized into the study regardless of whether they received study medication.

Posted

Median

95% Confidence Interval

Months

From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

ID	Title	Description
OG000	Sunitinib 50 mg (Schedule 4/2)	Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
OG001	Sunitinib 37.5 mg	Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.

Other Pre-specified

Functional Assessment of Cancer Therapy-General (FACT-G)

FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population.FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL(HRQoL):Physical Well-being(PWB),Social/Family Well-Being (SWB),Emotional Well-Being (EWB) and Functional Well-Being (FWB);each ranging from 0 (not at all) to 4 (very much) so that FACT-G ranged between 0-108.Since questions could be reversed coded, as appropriate, before calculating FACT-G,0 and 108 could be considered worst and best health states.

ITT population included all participants who were randomized into the study regardless of whether they received study medication.

Posted

Mean

Standard Deviation

Units on a scale

From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

ID	Title	Description
OG000	Sunitinib 50 mg (Schedule 4/2)	Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
OG001	Sunitinib 37.5 mg	Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.

Other Pre-specified

FACT-Kidney Symptom Index for Disease Related Symptoms (FKSI-DRS)

FKSI-DRS is a subset of FKSI which is a questionnaire for Functional Assessment of Cancer Therapy -Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer.

The FKSI contained 15 questions and the FKSI-DRS consisted of 9 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI-DRS ranged between 0-36. Since the questions could be reversed coded, as appropriate, before calculating FKSI-DRS, 0 and 36 could be considered the worst and best health states based on the 9 questions comprising FKSI-DRS.

ITT population included all participants who were randomized into the study regardless of whether they received study medication.

Posted

Mean

Standard Deviation

Units on scale

From date of randomization until the date of first documented progression or date of death due to any cause, assessed up to a maximum of 2 years

ID	Title	Description
OG000	Sunitinib 50 mg (Schedule 4/2)	Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
OG001	Sunitinib 37.5 mg	Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sunitinib 37.5 mg + Interferon Alpha-2b	Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.	7	25	25	25
EG001	Sunitinib 50 mg (Schedule 4/2)	Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.	50	146	144	146
EG002	Sunitinib 37.5 mg	Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.	54	143	142	143

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected25 at risk EG0013 affected146 at risk EG0022 affected143 at risk
Myocardial infarction	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected25 at risk EG0013 affected146 at risk EG0023 affected143 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected146 at risk EG0022 affected143 at risk
Haemoglobin decreased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected25 at risk EG0016 affected146 at risk EG00212 affected143 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected25 at risk EG0012 affected146 at risk EG0020 affected143 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected146 at risk EG0022 affected143 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Convulsion	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Syncope	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected25 at risk EG0011 affected146 at risk EG0023 affected143 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected25 at risk EG0012 affected146 at risk EG0023 affected143 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 affected25 at risk EG0012 affected146 at risk EG0022 affected143 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Disseminated intravascular coagulati	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0022 affected143 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Cardiac arrest	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected146 at risk EG0020 affected143 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected146 at risk EG0021 affected143 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Gastritis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0021 affected143 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0013 affected146 at risk EG0021 affected143 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0021 affected143 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0013 affected146 at risk EG0022 affected143 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0013 affected146 at risk EG0023 affected143 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Ascites	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Pyrexia	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0014 affected146 at risk EG0021 affected143 at risk
Device dislocation	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Asthenia	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0013 affected146 at risk EG0020 affected143 at risk
Disease progression	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0017 affected146 at risk EG00211 affected143 at risk
Fatigue	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0021 affected143 at risk
Oedema peripheral	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Pain	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Hypersensitivity	Immune system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Cellulitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Bacteraemia	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0021 affected143 at risk
Pneumonia	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0013 affected146 at risk EG0023 affected143 at risk
Retroperitoneal abscess	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Sinusitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Subacute endocarditis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0013 affected146 at risk EG0020 affected143 at risk
Viral infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0021 affected143 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0021 affected143 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0025 affected143 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected146 at risk EG0022 affected143 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0022 affected143 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected146 at risk EG0020 affected143 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Embolic stroke	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0021 affected143 at risk
Demyelination	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Headache	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Dizziness	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0022 affected143 at risk
Presyncope	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Confusional state	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0021 affected143 at risk
Delirium	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Mental status changes	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected146 at risk EG0020 affected143 at risk
Bladder neck obstruction	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Renal failure	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0022 affected143 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected146 at risk EG0024 affected143 at risk
Renal haemorrhage	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Haematuria	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0023 affected143 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0022 affected143 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0013 affected146 at risk EG0022 affected143 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0012 affected146 at risk EG0024 affected143 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Wound drainage	Surgical and medical procedures	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Aortic dissection	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0021 affected143 at risk
Arterial insufficiency	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Hypotension	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0010 affected146 at risk EG0024 affected143 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Shock	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk
Microangiopathy	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0011 affected146 at risk EG0020 affected143 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA 13.0	Non-systematic Assessment	EG00025 affected25 at risk EG00194 affected146 at risk EG002100 affected143 at risk
Pyrexia	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0008 affected25 at risk EG00123 affected146 at risk EG00217 affected143 at risk
Chills	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0007 affected25 at risk EG00114 affected146 at risk EG00218 affected143 at risk
Influenza like illness	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Mucosal inflammation	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG00141 affected146 at risk EG00236 affected143 at risk
Oedema peripheral	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG00129 affected146 at risk EG00226 affected143 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG00020 affected25 at risk EG00185 affected146 at risk EG00298 affected143 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG00014 affected25 at risk EG00191 affected146 at risk EG00276 affected143 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG00013 affected25 at risk EG00132 affected146 at risk EG00233 affected143 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG00010 affected25 at risk EG00137 affected146 at risk EG00236 affected143 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0008 affected25 at risk EG00148 affected146 at risk EG00248 affected143 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 affected25 at risk EG00140 affected146 at risk EG00239 affected143 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 affected25 at risk EG00116 affected146 at risk EG00215 affected143 at risk
Oral pain	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 affected25 at risk EG00119 affected146 at risk EG00218 affected143 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 affected25 at risk EG00119 affected146 at risk EG0027 affected143 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG00112 affected146 at risk EG0022 affected143 at risk
Glossitis	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG00110 affected146 at risk EG0027 affected143 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG0017 affected146 at risk EG0028 affected143 at risk
Dysgeusia	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0007 affected25 at risk EG00155 affected146 at risk EG00249 affected143 at risk
Dizziness	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected25 at risk EG00122 affected146 at risk EG00220 affected143 at risk
Headache	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 affected25 at risk EG00133 affected146 at risk EG00223 affected143 at risk
Paraesthesia	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Ageusia	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0007 affected25 at risk EG00122 affected146 at risk EG00220 affected143 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected25 at risk EG00146 affected146 at risk EG00236 affected143 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected25 at risk EG00136 affected146 at risk EG00244 affected143 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 affected25 at risk EG00110 affected146 at risk EG00210 affected143 at risk
Yellow skin	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 affected25 at risk EG0018 affected146 at risk EG0027 affected143 at risk
Hair colour changes	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG00118 affected146 at risk EG00221 affected143 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG00014 affected25 at risk EG00124 affected146 at risk EG00219 affected143 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0009 affected25 at risk EG00135 affected146 at risk EG00228 affected143 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0007 affected25 at risk EG0018 affected146 at risk EG0025 affected143 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0005 affected25 at risk EG00125 affected146 at risk EG00227 affected143 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG00010 affected25 at risk EG00129 affected146 at risk EG00226 affected143 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected25 at risk EG00134 affected146 at risk EG00225 affected143 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0004 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG00129 affected146 at risk EG00231 affected143 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG00011 affected25 at risk EG00146 affected146 at risk EG00259 affected143 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected25 at risk EG00120 affected146 at risk EG00225 affected143 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected25 at risk EG00114 affected146 at risk EG00211 affected143 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0003 affected25 at risk EG00132 affected146 at risk EG00223 affected143 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG00129 affected146 at risk EG00224 affected143 at risk
Alanine aminotransferase increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0003 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Weight decreased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0003 affected25 at risk EG00120 affected146 at risk EG00230 affected143 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
White blood cell count decreased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Hypertension	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 affected25 at risk EG00146 affected146 at risk EG00242 affected143 at risk
Accelerated hypertension	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG00110 affected146 at risk EG0028 affected143 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 13.0	Non-systematic Assessment	EG0002 affected25 at risk EG0010 affected146 at risk EG0020 affected143 at risk
Hypothyroidism	Endocrine disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00119 affected146 at risk EG00211 affected143 at risk
Lacrimation increased	Eye disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0018 affected146 at risk EG0027 affected143 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00111 affected146 at risk EG0029 affected143 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00111 affected146 at risk EG00212 affected143 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00112 affected146 at risk EG0025 affected143 at risk
Flatulence	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00110 affected146 at risk EG00212 affected143 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0016 affected146 at risk EG0028 affected143 at risk
Toothache	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0018 affected146 at risk EG0023 affected143 at risk
Asthenia	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00113 affected146 at risk EG00216 affected143 at risk
Chest pain	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0017 affected146 at risk EG0028 affected143 at risk
Pain	General disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0014 affected146 at risk EG00213 affected143 at risk
Sinusitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00111 affected146 at risk EG0023 affected143 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00112 affected146 at risk EG0025 affected143 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0018 affected146 at risk EG00212 affected143 at risk
Blood creatinine increased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00111 affected146 at risk EG00211 affected143 at risk
Haemoglobin decreased	Investigations	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0016 affected146 at risk EG00211 affected143 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00110 affected146 at risk EG00221 affected143 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0015 affected146 at risk EG0028 affected143 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00113 affected146 at risk EG0026 affected143 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0015 affected146 at risk EG0028 affected143 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0019 affected146 at risk EG0029 affected143 at risk
Anxiety	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00114 affected146 at risk EG00211 affected143 at risk
Depression	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00110 affected146 at risk EG00218 affected143 at risk
Insomnia	Psychiatric disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00127 affected146 at risk EG00222 affected143 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00111 affected146 at risk EG00213 affected143 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0018 affected146 at risk EG00216 affected143 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00112 affected146 at risk EG0027 affected143 at risk
Periorbital oedema	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0019 affected146 at risk EG0027 affected143 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG00110 affected146 at risk EG0023 affected143 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 affected25 at risk EG0019 affected146 at risk EG0025 affected143 at risk

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D007680	Kidney Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases