Phase II Study of Afinitor vs. Sutent in Patients With Me... | NCT01108445

ID	Type	Description	Link
CRAD001L2402T	Other Identifier	Novartis

Name	Class
Novartis	INDUSTRY
Pfizer	INDUSTRY

Label	Type	Description	Intervention Names
RAD001	Active Comparator	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.	Drug: Everolimus
Sunitinib	Active Comparator	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.	Drug: Sunitinib

Name	Type	Description	Arm Group Labels	Other Names
Everolimus	Drug	Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.	RAD001

Measure	Description	Time Frame
Anti-tumor Activity as Measured by Median Progression Free Survival Time	The primary objective will be to compare the anti-tumor activity of everolimus and sunitinib in subjects with mRCC with non-clear cell pathology, as measured by progression-free survival (PFS) following treatment initiation according to RECIST 1.1 criteria. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).	24 Months

Measure	Description	Time Frame
Progression Free Survival Rates	6-, 12-, and 24-month rates of PFS in each arm will be compared for each treatment arm. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Measure	Description	Time Frame
Clinical Measures of Response and PFS With Baseline and Time-dependent Levels of Biomarkers	To correlate clinical measures of response and PFS with baseline and time-dependent levels of biomarkers. These biomarkers include plasma angiokine levels, tissue immunohistochemical and genomic profiles, copy number as assessed by array-based comparative genomic hybridization (CGH), and known mutations in non-clear cell RCC

Name	Affiliation	Role
Andrew Armstrong, MD, ScM	Duke University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago		Chicago	Illinois	60637	United States
Indiana University Melvin and Bran Simon Cancer Center

PubMed Identifier	Type	Citation	Retractions
37146227	Derived	Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
26794930

ID	Title	Description
FG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
FG001

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

Anti-tumor Activity as Measured by Median Progression Free Survival Time

The primary objective will be to compare the anti-tumor activity of everolimus and sunitinib in subjects with mRCC with non-clear cell pathology, as measured by progression-free survival (PFS) following treatment initiation according to RECIST 1.1 criteria. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Posted

Median

80% Confidence Interval

Months

24 Months

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Units	Counts
Participants	OG00057 OG00151

Title

Denominators

Categories

Title	Measurements
	OG0005.6(5.5 to 6.0) OG0018.3(5.8 to 11.4)

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		0.157		Hazard Ratio (HR)	1.406			2-Sided								Superiority or Other

Secondary

Progression Free Survival Rates

6-, 12-, and 24-month rates of PFS in each arm will be compared for each treatment arm. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Posted

Number

95% Confidence Interval

percentage of participants

6, 12 and 24 months

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Units	Counts
Participants

Secondary

PFS Expressed in Months

Progression-free survival (PFS) expressed in months as compared to an historic control (interferon-treated clear cell RCC control arm from the sunitinib phase III study). Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Posted

Median

95% Confidence Interval

Months

24 months

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Units	Counts

Secondary

Overall Response Rate

Defined as complete response [CR] and partial response [PR] by RECIST 1.1 criteria in each treatment arm.Overall Response Rate (ORR) = CR + PR. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Posted

Number

95% Confidence Interval

percentage of participants

24 months

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Units	Counts
Participants

Secondary

Percentage of Participants With Stable Disease (SD)

Percentage of participants with stable disease during treatment is defined as stable disease [SD] by RECIST 1.1 criteria as calculated in each treatment arm. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to 36 months

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Units	Counts
Participants

Secondary

12 Week Clinical Benefit Rate as Percentage

Rate of complete or partial response or stable disease by the RECIST 1.1 criteria lasting ≥ 12 weeks prior to progression. Benefit rate is defined as complete response [CR] and partial response [PR] and stable disease [SD] by RECIST 1.1 criteria in each treatment arm. Benefit rate = CR + PR + SD. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Posted

Number

95% Confidence Interval

percentage of particpants

Baseline to 36 months

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Secondary

Overall Survival Rates

To compare overall survival (OS) rates at 6, 12, 24, and 36 months and over time in each treatment arm.

Posted

Number

95% Confidence Interval

percentage probability

6, 12, 24, 36 months

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Units	Counts
Participants	OG000

Secondary

Best Tumor Shrinkage as a Percentile in Each Arm

To compare the best tumor shrinkage as a percentile in each treatment arm. The percentile change at each follow up visit is calculated by measuring the percentage change in the Sum of lesion measurement from baseline. The best tumor shrinkage is lowest percentile change. A decrease is indicated by a negative percentage.

Posted

Median

Inter-Quartile Range

percentile decrease

24 months

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Units	Counts
Participants

Secondary

Median Duration of Response (CR, PR, and SD)

To compare the median duration of response (CR, PR, and SD) in each treatment arm. According to RECIST 1.1, Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Posted

Median

Inter-Quartile Range

months

24 months

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Units	Counts

Secondary

Median OS

To compare the median OS in each treatment arm.

Posted

Median

95% Confidence Interval

months

Up to 40 months

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Units	Counts
Participants	OG000

Secondary

Time-to-new Metastatic Disease in Each Treatment Arm

To compare the time-to-new metastatic disease in each treatment arm, defined from the date of first study agent administration to the onset of a new evaluable site of disease, excluding the primary site and all sites documented at baseline

Posted

Median

95% Confidence Interval

months

36 months

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Adverse Events

To assess toxicities associated with everolimus or sunitinib using NCI CTC version 4.0 criteria

Posted

Number

95% Confidence Interval

percentage of participants

24 months

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Units	Counts
Participants	OG000

Secondary

Change in Quality-of-life

To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and cycle 3 day 1 per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT-Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.

All participants who completed the cycle 3 day 1 visit.

Posted

Mean

Standard Deviation

units on a scale

baseline, cycle 3 day 1

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Secondary

Change in Quality-of-life

To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and cycle 6 day1 per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT-Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.

All participants who completed the cycle 6 day 1 visit.

Posted

Mean

Standard Deviation

units on a scale

baseline, cycle 6 day 1

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Secondary

Change in Quality-of-life

To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and end of treatment per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT-Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.

All participants who completed the End of treatment visit.

Posted

Mean

Standard Deviation

units on a scale

baseline, up to 40 months

ID	Title	Description
OG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
OG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.

Other Pre-specified

Clinical Measures of Response and PFS With Baseline and Time-dependent Levels of Biomarkers

To correlate clinical measures of response and PFS with baseline and time-dependent levels of biomarkers. These biomarkers include plasma angiokine levels, tissue immunohistochemical and genomic profiles, copy number as assessed by array-based comparative genomic hybridization (CGH), and known mutations in non-clear cell RCC

Not Posted

36 months

Participants

Other Pre-specified

Changes in Copy Number, RNA Expression, and Immunohistochemical Profiles

To evaluate in an exploratory fashion changes in copy number, RNA expression, and immunohistochemical profiles by microarray between primary non-clear cell RCC tumors and metastatic samples

Not Posted

36 months

Participants

Other Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG00016 affected57 at risk EG00114 affected51 at risk
Leukopenia	Blood and lymphatic system disorders	EG0002 affected57 at risk EG0014 affected51 at risk
Lymphadenopathy	Blood and lymphatic system disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Lymphopenia	Blood and lymphatic system disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Neutropenia	Blood and lymphatic system disorders	EG0001 affected57 at risk EG0015 affected51 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG0007 affected57 at risk EG00112 affected51 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Palpitations	Cardiac disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Tachycardia	Cardiac disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Bradycardia	Cardiac disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Cardiac flutter	Cardiac disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Left ventricular hypertrophy	Cardiac disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Ear disorder	Ear and labyrinth disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Ear pain	Ear and labyrinth disorders	EG0002 affected57 at risk EG0010 affected51 at risk
Ear pruritus	Ear and labyrinth disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Otorrhoea	Ear and labyrinth disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Tinnitus	Ear and labyrinth disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Hyperthyroidism	Endocrine disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Hypothyroidism	Endocrine disorders	EG0000 affected57 at risk EG0013 affected51 at risk
Cataract	Eye disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Conjunctivitis	Eye disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Dry eye	Eye disorders	EG0002 affected57 at risk EG0012 affected51 at risk
Eye discharge	Eye disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Eye irritation	Eye disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Eye pain	Eye disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Periorbital oedema	Eye disorders	EG0002 affected57 at risk EG0012 affected51 at risk
Vision blurred	Eye disorders	EG0002 affected57 at risk EG0010 affected51 at risk
Conjunctival hyperaemia	Eye disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Conjunctival oedema	Eye disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Conjunctival pallor	Eye disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Eye swelling	Eye disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Eyelid oedema	Eye disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Glaucoma	Eye disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Lacrimation increased	Eye disorders	EG0000 affected57 at risk EG0013 affected51 at risk
Photopsia	Eye disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Vitreous floaters	Eye disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Abdominal distension	Gastrointestinal disorders	EG0002 affected57 at risk EG0013 affected51 at risk
Abdominal pain	Gastrointestinal disorders	EG0007 affected57 at risk EG0017 affected51 at risk
Abdominal pain lower	Gastrointestinal disorders	EG0001 affected57 at risk EG0012 affected51 at risk
Abdominal pain upper	Gastrointestinal disorders	EG0003 affected57 at risk EG0015 affected51 at risk
Ascites	Gastrointestinal disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Cheilitis	Gastrointestinal disorders	EG0004 affected57 at risk EG0010 affected51 at risk
Constipation	Gastrointestinal disorders	EG00010 affected57 at risk EG00115 affected51 at risk
Diarrhoea	Gastrointestinal disorders	EG00015 affected57 at risk EG00134 affected51 at risk
Dry mouth	Gastrointestinal disorders	EG0004 affected57 at risk EG0015 affected51 at risk
Dyspepsia	Gastrointestinal disorders	EG0005 affected57 at risk EG00111 affected51 at risk
Dysphagia	Gastrointestinal disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Faeces discoloured	Gastrointestinal disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Flatulence	Gastrointestinal disorders	EG0001 affected57 at risk EG0016 affected51 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	EG0001 affected57 at risk EG0018 affected51 at risk
Gingival pain	Gastrointestinal disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Inguinal hernia	Gastrointestinal disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Lip swelling	Gastrointestinal disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Mouth ulceration	Gastrointestinal disorders	EG0005 affected57 at risk EG0011 affected51 at risk
Nausea	Gastrointestinal disorders	EG00026 affected57 at risk EG00136 affected51 at risk
Oral pain	Gastrointestinal disorders	EG0002 affected57 at risk EG0014 affected51 at risk
Small intestinal obstruction	Gastrointestinal disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Stomatitis	Gastrointestinal disorders	EG00027 affected57 at risk EG00114 affected51 at risk
Tongue blistering	Gastrointestinal disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Vomiting	Gastrointestinal disorders	EG00013 affected57 at risk EG00117 affected51 at risk
Abdominal discomfort	Gastrointestinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Anal inflammation	Gastrointestinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Dental caries	Gastrointestinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Gingival bleeding	Gastrointestinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Gingival hypertrophy	Gastrointestinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Glossodynia	Gastrointestinal disorders	EG0000 affected57 at risk EG0012 affected51 at risk
Haematochezia	Gastrointestinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Haemorrhoids	Gastrointestinal disorders	EG0000 affected57 at risk EG0012 affected51 at risk
Lip pain	Gastrointestinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Rectal haemorrhage	Gastrointestinal disorders	EG0000 affected57 at risk EG0013 affected51 at risk
Reflux oesophagitis	Gastrointestinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Toothache	Gastrointestinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Asthenia	General disorders	EG0001 affected57 at risk EG0012 affected51 at risk
Chest pain	General disorders	EG0002 affected57 at risk EG0010 affected51 at risk
Chills	General disorders	EG0004 affected57 at risk EG0013 affected51 at risk
Fatigue	General disorders	EG00033 affected57 at risk EG00131 affected51 at risk
Hernia	General disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Influenza like illness	General disorders	EG0003 affected57 at risk EG0012 affected51 at risk
Irritability	General disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Local swelling	General disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Mucosal inflammation	General disorders	EG00013 affected57 at risk EG00112 affected51 at risk
Non-cardiac chest pain	General disorders	EG0003 affected57 at risk EG0011 affected51 at risk
Oedema	General disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Oedema peripheral	General disorders	EG00015 affected57 at risk EG0018 affected51 at risk
Pain	General disorders	EG0004 affected57 at risk EG0015 affected51 at risk
Pyrexia	General disorders	EG0008 affected57 at risk EG0014 affected51 at risk
Chest discomfort	General disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Early satiety	General disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Impaired healing	General disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Hepatotoxicity	Hepatobiliary disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Drug hypersensitivity	Immune system disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Seasonal allergy	Immune system disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Blister infected	Infections and infestations	EG0001 affected57 at risk EG0010 affected51 at risk
Cellulitis	Infections and infestations	EG0001 affected57 at risk EG0011 affected51 at risk
Cystitis	Infections and infestations	EG0001 affected57 at risk EG0010 affected51 at risk
Ear infection	Infections and infestations	EG0004 affected57 at risk EG0011 affected51 at risk
Folliculitis	Infections and infestations	EG0001 affected57 at risk EG0012 affected51 at risk
Furuncle	Infections and infestations	EG0001 affected57 at risk EG0011 affected51 at risk
Hepatitis B	Infections and infestations	EG0001 affected57 at risk EG0010 affected51 at risk
Infection	Infections and infestations	EG0001 affected57 at risk EG0010 affected51 at risk
Influenza	Infections and infestations	EG0001 affected57 at risk EG0011 affected51 at risk
Localised infection	Infections and infestations	EG0001 affected57 at risk EG0010 affected51 at risk
Lower respiratory tract infection	Infections and infestations	EG0002 affected57 at risk EG0011 affected51 at risk
Lung infection	Infections and infestations	EG0001 affected57 at risk EG0010 affected51 at risk
Lymph gland infection	Infections and infestations	EG0001 affected57 at risk EG0010 affected51 at risk
Nasopharyngitis	Infections and infestations	EG0003 affected57 at risk EG0010 affected51 at risk
Paronychia	Infections and infestations	EG0002 affected57 at risk EG0011 affected51 at risk
Pneumonia	Infections and infestations	EG0001 affected57 at risk EG0011 affected51 at risk
Rash pustular	Infections and infestations	EG0001 affected57 at risk EG0011 affected51 at risk
Respiratory tract infection	Infections and infestations	EG0001 affected57 at risk EG0011 affected51 at risk
Rhinitis	Infections and infestations	EG0001 affected57 at risk EG0010 affected51 at risk
Sinusitis	Infections and infestations	EG0002 affected57 at risk EG0011 affected51 at risk
Soft tissue infection	Infections and infestations	EG0001 affected57 at risk EG0010 affected51 at risk
Urinary tract infection	Infections and infestations	EG0002 affected57 at risk EG0014 affected51 at risk
Candidiasis	Infections and infestations	EG0000 affected57 at risk EG0011 affected51 at risk
Gastroenteritis viral	Infections and infestations	EG0000 affected57 at risk EG0011 affected51 at risk
Hand-foot-and-mouth disease	Infections and infestations	EG0000 affected57 at risk EG0011 affected51 at risk
Oral candidiasis	Infections and infestations	EG0000 affected57 at risk EG0011 affected51 at risk
Peritonsillar abscess	Infections and infestations	EG0000 affected57 at risk EG0011 affected51 at risk
Pharyngitis	Infections and infestations	EG0000 affected57 at risk EG0011 affected51 at risk
Pyelonephritis	Infections and infestations	EG0000 affected57 at risk EG0011 affected51 at risk
Skin infection	Infections and infestations	EG0000 affected57 at risk EG0013 affected51 at risk
Tooth abscess	Infections and infestations	EG0000 affected57 at risk EG0012 affected51 at risk
Tooth infection	Infections and infestations	EG0000 affected57 at risk EG0011 affected51 at risk
Upper respiratory tract infection	Infections and infestations	EG0000 affected57 at risk EG0012 affected51 at risk
Urosepsis	Infections and infestations	EG0000 affected57 at risk EG0011 affected51 at risk
Viral infection	Infections and infestations	EG0000 affected57 at risk EG0011 affected51 at risk
Contusion	Injury, poisoning and procedural complications	EG0001 affected57 at risk EG0013 affected51 at risk
Procedural pain	Injury, poisoning and procedural complications	EG0002 affected57 at risk EG0010 affected51 at risk
Skin laceration	Injury, poisoning and procedural complications	EG0001 affected57 at risk EG0010 affected51 at risk
Heart injury	Injury, poisoning and procedural complications	EG0000 affected57 at risk EG0011 affected51 at risk
Joint sprain	Injury, poisoning and procedural complications	EG0000 affected57 at risk EG0011 affected51 at risk
Laceration	Injury, poisoning and procedural complications	EG0000 affected57 at risk EG0011 affected51 at risk
Post procedural swelling	Injury, poisoning and procedural complications	EG0000 affected57 at risk EG0011 affected51 at risk
Alanine aminotransferase increased	Investigations	EG0002 affected57 at risk EG0015 affected51 at risk
Aspartate aminotransferase increased	Investigations	EG0007 affected57 at risk EG00110 affected51 at risk
Blood alkaline phosphatase increased	Investigations	EG0003 affected57 at risk EG0013 affected51 at risk
Blood cholesterol increased	Investigations	EG0007 affected57 at risk EG0011 affected51 at risk
Blood creatine increased	Investigations	EG0002 affected57 at risk EG0010 affected51 at risk
Blood creatinine increased	Investigations	EG0006 affected57 at risk EG0019 affected51 at risk
Blood glucose increased	Investigations	EG0001 affected57 at risk EG0010 affected51 at risk
Blood magnesium decreased	Investigations	EG0001 affected57 at risk EG0010 affected51 at risk
Blood phosphorus decreased	Investigations	EG0001 affected57 at risk EG0010 affected51 at risk
Blood potassium decreased	Investigations	EG0001 affected57 at risk EG0011 affected51 at risk
Blood triglycerides increased	Investigations	EG0003 affected57 at risk EG0010 affected51 at risk
Blood urea increased	Investigations	EG0001 affected57 at risk EG0013 affected51 at risk
Chest X-ray abnormal	Investigations	EG0001 affected57 at risk EG0010 affected51 at risk
Glomerular filtration rate decreased	Investigations	EG0001 affected57 at risk EG0014 affected51 at risk
Haemoglobin decreased	Investigations	EG0001 affected57 at risk EG0011 affected51 at risk
Liver function test abnormal	Investigations	EG0002 affected57 at risk EG0012 affected51 at risk
Low density lipoprotein increased	Investigations	EG0001 affected57 at risk EG0010 affected51 at risk
Platelet count decreased	Investigations	EG0003 affected57 at risk EG0018 affected51 at risk
Weight decreased	Investigations	EG00010 affected57 at risk EG0017 affected51 at risk
Weight increased	Investigations	EG0001 affected57 at risk EG0011 affected51 at risk
Activated partial thromboplastin time prolonged	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Aspartate aminotransferase	Investigations	EG0000 affected57 at risk EG0012 affected51 at risk
Bacterial test positive	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Blood albumin decreased	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Blood bilirubin increased	Investigations	EG0000 affected57 at risk EG0013 affected51 at risk
Blood calcium decreased	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Blood ketone body increased	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Blood lactate dehydrogenase increased	Investigations	EG0000 affected57 at risk EG0013 affected51 at risk
Blood lactic acid increased	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Blood pressure increased	Investigations	EG0000 affected57 at risk EG0014 affected51 at risk
Blood thyroid stimulating hormone increased	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Clostridium test positive	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Electrocardiogram QT prolonged	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Haptoglobin decreased	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Lipase increased	Investigations	EG0000 affected57 at risk EG0012 affected51 at risk
Lymphocyte count decreased	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Mean cell haemoglobin increased	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Neutrophil count decreased	Investigations	EG0000 affected57 at risk EG0018 affected51 at risk
Protein total decreased	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Protein total increased	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Transaminases increased	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
Urine output decreased	Investigations	EG0000 affected57 at risk EG0011 affected51 at risk
White blood cell count decreased	Investigations	EG0000 affected57 at risk EG0018 affected51 at risk
Decreased appetite	Metabolism and nutrition disorders	EG00015 affected57 at risk EG00130 affected51 at risk
Dehydration	Metabolism and nutrition disorders	EG0002 affected57 at risk EG0014 affected51 at risk
Diabetes mellitus	Metabolism and nutrition disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Failure to thrive	Metabolism and nutrition disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Gout	Metabolism and nutrition disorders	EG0002 affected57 at risk EG0011 affected51 at risk
Hypercalcaemia	Metabolism and nutrition disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Hyperglycaemia	Metabolism and nutrition disorders	EG0007 affected57 at risk EG0014 affected51 at risk
Hyperkalaemia	Metabolism and nutrition disorders	EG0003 affected57 at risk EG0014 affected51 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	EG0001 affected57 at risk EG0012 affected51 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	EG0008 affected57 at risk EG0010 affected51 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	EG0002 affected57 at risk EG0013 affected51 at risk
Hypocalcaemia	Metabolism and nutrition disorders	EG0001 affected57 at risk EG0012 affected51 at risk
Hypoglycaemia	Metabolism and nutrition disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG0002 affected57 at risk EG0012 affected51 at risk
Hyponatraemia	Metabolism and nutrition disorders	EG0005 affected57 at risk EG0017 affected51 at risk
Hypophosphataemia	Metabolism and nutrition disorders	EG0003 affected57 at risk EG0015 affected51 at risk
Acidosis	Metabolism and nutrition disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Hyperammonaemia	Metabolism and nutrition disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Hyperamylasaemia	Metabolism and nutrition disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Hyperlipasaemia	Metabolism and nutrition disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Hypernatraemia	Metabolism and nutrition disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Hyperuricaemia	Metabolism and nutrition disorders	EG0000 affected57 at risk EG0013 affected51 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	EG0000 affected57 at risk EG0015 affected51 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG0007 affected57 at risk EG00112 affected51 at risk
Back pain	Musculoskeletal and connective tissue disorders	EG0006 affected57 at risk EG00115 affected51 at risk
Bone pain	Musculoskeletal and connective tissue disorders	EG0003 affected57 at risk EG0010 affected51 at risk
Flank pain	Musculoskeletal and connective tissue disorders	EG0005 affected57 at risk EG0017 affected51 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	EG0001 affected57 at risk EG0012 affected51 at risk
Muscle mass	Musculoskeletal and connective tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	EG0002 affected57 at risk EG0012 affected51 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	EG0006 affected57 at risk EG0012 affected51 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	EG0004 affected57 at risk EG0014 affected51 at risk
Myalgia	Musculoskeletal and connective tissue disorders	EG0002 affected57 at risk EG0012 affected51 at risk
Neck pain	Musculoskeletal and connective tissue disorders	EG0001 affected57 at risk EG0012 affected51 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	EG0005 affected57 at risk EG0017 affected51 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Soft tissue disorder	Musculoskeletal and connective tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Groin pain	Musculoskeletal and connective tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Muscle swelling	Musculoskeletal and connective tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	EG0000 affected57 at risk EG0012 affected51 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected57 at risk EG0011 affected51 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected57 at risk EG0011 affected51 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected57 at risk EG0011 affected51 at risk
Ageusia	Nervous system disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Dizziness	Nervous system disorders	EG0003 affected57 at risk EG0016 affected51 at risk
Dysgeusia	Nervous system disorders	EG00018 affected57 at risk EG00125 affected51 at risk
Headache	Nervous system disorders	EG0006 affected57 at risk EG0015 affected51 at risk
Lethargy	Nervous system disorders	EG0009 affected57 at risk EG00110 affected51 at risk
Loss of consciousness	Nervous system disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Migraine	Nervous system disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Neuropathy peripheral	Nervous system disorders	EG0003 affected57 at risk EG0013 affected51 at risk
Paraesthesia	Nervous system disorders	EG0002 affected57 at risk EG0011 affected51 at risk
Peripheral motor neuropathy	Nervous system disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Asterixis	Nervous system disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Disturbance in attention	Nervous system disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Dysarthria	Nervous system disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Encephalomalacia	Nervous system disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Hepatic encephalopathy	Nervous system disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Hyperaesthesia	Nervous system disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Neurotoxicity	Nervous system disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Parosmia	Nervous system disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Peripheral sensory neuropathy	Nervous system disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	EG0000 affected57 at risk EG0011 affected51 at risk
Depressed mood	Psychiatric disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Depression	Psychiatric disorders	EG0002 affected57 at risk EG0013 affected51 at risk
Insomnia	Psychiatric disorders	EG0006 affected57 at risk EG0013 affected51 at risk
Mental status changes	Psychiatric disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Mood altered	Psychiatric disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Sleep disorder	Psychiatric disorders	EG0002 affected57 at risk EG0011 affected51 at risk
Anxiety	Psychiatric disorders	EG0000 affected57 at risk EG0018 affected51 at risk
Confusional state	Psychiatric disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Dysphoria	Psychiatric disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Emotional distress	Psychiatric disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Restlessness	Psychiatric disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Bladder hypertrophy	Renal and urinary disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Bladder spasm	Renal and urinary disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Cystitis noninfective	Renal and urinary disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Dysuria	Renal and urinary disorders	EG0002 affected57 at risk EG0012 affected51 at risk
Haematuria	Renal and urinary disorders	EG0003 affected57 at risk EG0015 affected51 at risk
Micturition urgency	Renal and urinary disorders	EG0002 affected57 at risk EG0010 affected51 at risk
Nocturia	Renal and urinary disorders	EG0002 affected57 at risk EG0010 affected51 at risk
Pollakiuria	Renal and urinary disorders	EG0006 affected57 at risk EG0011 affected51 at risk
Proteinuria	Renal and urinary disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Renal failure acute	Renal and urinary disorders	EG0001 affected57 at risk EG0013 affected51 at risk
Urinary tract pain	Renal and urinary disorders	EG0002 affected57 at risk EG0011 affected51 at risk
Azotaemia	Renal and urinary disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Chromaturia	Renal and urinary disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Renal impairment	Renal and urinary disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Renal tubular necrosis	Renal and urinary disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Urinary incontinence	Renal and urinary disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Urine flow decreased	Renal and urinary disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Oedema genital	Reproductive system and breast disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Perineal pain	Reproductive system and breast disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Scrotal swelling	Reproductive system and breast disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Breast discomfort	Reproductive system and breast disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Genital rash	Reproductive system and breast disorders	EG0000 affected57 at risk EG0012 affected51 at risk
Pruritus genital	Reproductive system and breast disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Scrotal oedema	Reproductive system and breast disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG00025 affected57 at risk EG0018 affected51 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG00021 affected57 at risk EG0019 affected51 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	EG0004 affected57 at risk EG0012 affected51 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	EG00011 affected57 at risk EG0017 affected51 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	EG0001 affected57 at risk EG0012 affected51 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	EG0001 affected57 at risk EG0012 affected51 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	EG0005 affected57 at risk EG0011 affected51 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Pharyngeal inflammation	Respiratory, thoracic and mediastinal disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	EG0005 affected57 at risk EG0010 affected51 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	EG0003 affected57 at risk EG0011 affected51 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	EG0002 affected57 at risk EG0010 affected51 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Rales	Respiratory, thoracic and mediastinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Rhinalgia	Respiratory, thoracic and mediastinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Alopecia	Skin and subcutaneous tissue disorders	EG0002 affected57 at risk EG0014 affected51 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0014 affected51 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Dry skin	Skin and subcutaneous tissue disorders	EG00011 affected57 at risk EG0017 affected51 at risk
Eczema	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Erythema	Skin and subcutaneous tissue disorders	EG0003 affected57 at risk EG0014 affected51 at risk
Hair colour changes	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0012 affected51 at risk
Hair growth abnormal	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Nail disorder	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Pain of skin	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	EG0008 affected57 at risk EG00121 affected51 at risk
Petechiae	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Pruritus	Skin and subcutaneous tissue disorders	EG0009 affected57 at risk EG0017 affected51 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Rash	Skin and subcutaneous tissue disorders	EG00018 affected57 at risk EG00111 affected51 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	EG0006 affected57 at risk EG0012 affected51 at risk
Rash papular	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Skin lesion	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Skin reaction	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0012 affected51 at risk
Skin toxicity	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Urticaria	Skin and subcutaneous tissue disorders	EG0001 affected57 at risk EG0010 affected51 at risk
Cold sweat	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0012 affected51 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0013 affected51 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Night sweats	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0013 affected51 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Plantar erythema	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Purpura	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Rash macular	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Scab	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Skin disorder	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0012 affected51 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Swelling face	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0011 affected51 at risk
Yellow skin	Skin and subcutaneous tissue disorders	EG0000 affected57 at risk EG0013 affected51 at risk
Deep vein thrombosis	Vascular disorders	EG0001 affected57 at risk EG0011 affected51 at risk
Flushing	Vascular disorders	EG0003 affected57 at risk EG0011 affected51 at risk
Hot flush	Vascular disorders	EG0002 affected57 at risk EG0013 affected51 at risk
Hypertension	Vascular disorders	EG0006 affected57 at risk EG00123 affected51 at risk
Hypotension	Vascular disorders	EG0001 affected57 at risk EG0014 affected51 at risk
Thrombophlebitis superficial	Vascular disorders	EG0001 affected57 at risk EG0010 affected51 at risk

ID	Term
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

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
BG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 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	RAD001	Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle. Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.			36	57	57	57
EG001	Sunitinib	Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle. Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.			41	51	51	51