Trial Outcomes & Findings for Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer (NCT NCT01064310)
NCT ID: NCT01064310
Last Updated: 2017-04-17
Results Overview
The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
169 participants
Primary outcome timeframe
End of treatment of both study drugs (maximum of 22 weeks)
Results posted on
2017-04-17
Participant Flow
There were169 participants randomized and one participant randomized in error with no data available
Participant milestones
| Measure |
Sunitinib 50 mg Followed by Pazopanib 800 mg
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Pazopanib 800 mg Followed by Sunitinib 50 mg
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Open Label Pazopinib
To provide continued access to treatment
|
|---|---|---|---|
|
Period 1
STARTED
|
82
|
86
|
0
|
|
Period 1
COMPLETED
|
68
|
68
|
0
|
|
Period 1
NOT COMPLETED
|
14
|
18
|
0
|
|
Period 2
STARTED
|
68
|
68
|
0
|
|
Period 2
COMPLETED
|
64
|
62
|
0
|
|
Period 2
NOT COMPLETED
|
4
|
6
|
0
|
|
Open Label Pazopinib
STARTED
|
0
|
0
|
84
|
|
Open Label Pazopinib
COMPLETED
|
0
|
0
|
0
|
|
Open Label Pazopinib
NOT COMPLETED
|
0
|
0
|
84
|
Reasons for withdrawal
| Measure |
Sunitinib 50 mg Followed by Pazopanib 800 mg
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Pazopanib 800 mg Followed by Sunitinib 50 mg
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Open Label Pazopinib
To provide continued access to treatment
|
|---|---|---|---|
|
Period 1
Adverse Event
|
7
|
10
|
0
|
|
Period 1
Physician Decision
|
1
|
0
|
0
|
|
Period 1
Withdrawal by Subject
|
2
|
2
|
0
|
|
Period 1
Lack of Efficacy
|
3
|
5
|
0
|
|
Period 1
Entered Open-label Period
|
1
|
1
|
0
|
|
Period 2
Adverse Event
|
2
|
1
|
0
|
|
Period 2
Physician Decision
|
0
|
1
|
0
|
|
Period 2
Entered Open-label Period
|
1
|
0
|
0
|
|
Period 2
Lack of Efficacy
|
1
|
4
|
0
|
|
Open Label Pazopinib
Withdrawal by Subject
|
0
|
0
|
1
|
|
Open Label Pazopinib
Adverse Event
|
0
|
0
|
12
|
|
Open Label Pazopinib
Lack of Efficacy
|
0
|
0
|
51
|
|
Open Label Pazopinib
Physician Decision
|
0
|
0
|
20
|
Baseline Characteristics
Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Sunitinib 50 mg Followed by Pazopanib 800 mg
n=82 Participants
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Pazopanib 800 mg Followed by Sunitinib 50 mg
n=86 Participants
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 Years
STANDARD_DEVIATION 9.56 • n=5 Participants
|
62.2 Years
STANDARD_DEVIATION 11.35 • n=7 Participants
|
62.2 Years
STANDARD_DEVIATION 10.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Central/South Asian Heritage
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
74 participants
n=5 Participants
|
83 participants
n=7 Participants
|
157 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of treatment of both study drugs (maximum of 22 weeks)Population: Modified-Intent-to-Treat (mITT) Population (used for the primary analysis): participants who received at least one dose of study treatment from each treatment period and who did not have documented progressive disease (PD) at the end of Treatment Period 1 and completed the patient preference questionnaire.
The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
Outcome measures
| Measure |
Sunitinib 50 mg Followed by Pazopanib 800 mg
n=60 Participants
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Pazopanib 800 mg Followed by Sunitinib 50 mg
n=54 Participants
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
|---|---|---|
|
Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)
Pazopanib
|
37 participants
|
43 participants
|
|
Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)
No preference
|
4 participants
|
5 participants
|
|
Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)
Sunitinib
|
19 participants
|
6 participants
|
PRIMARY outcome
Timeframe: End of treatment of both study drugs (maximum of 22 weeks)Population: mITT Population. Responses to some categories of the PPQ may be missing for some participants.
The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
Outcome measures
| Measure |
Sunitinib 50 mg Followed by Pazopanib 800 mg
n=25 Participants
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Pazopanib 800 mg Followed by Sunitinib 50 mg
n=80 Participants
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
|---|---|---|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Soreness in mouth/throat had less impact, No
|
8 participants
|
25 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Loss of appetite had less impact, Yes
|
10 participants
|
28 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Loss of appetite had less impact, No
|
8 participants
|
28 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Nausea/vomiting had less impact, NA
|
7 participants
|
17 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Diarrhea had less impact, NA
|
4 participants
|
15 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Pain in stomach area had less impact, No
|
4 participants
|
30 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Changes in food tastes had less impact, Yes
|
5 participants
|
44 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Quality of life better, Yes
|
15 participants
|
65 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Other, Yes
|
5 participants
|
14 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Other, No
|
0 participants
|
0 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Fatigue had less impact on life, Yes
|
12 participants
|
47 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Fatigue had less impact on life, No
|
8 participants
|
26 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Fatigue had less impact on life, not applicable (N
|
5 participants
|
6 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Soreness in hands/feet had less impact, Yes
|
6 participants
|
30 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Soreness in hands/feet had less impact, No
|
7 participants
|
22 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Soreness in hands/feet had less impact, NA
|
12 participants
|
28 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Soreness in mouth/throat had less impact, Yes
|
6 participants
|
32 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Soreness in mouth/throat had less impact, NA
|
11 participants
|
23 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Loss of appetite had less impact, NA
|
7 participants
|
22 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Change in hair color had less impact, Yes
|
5 participants
|
9 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Change in hair color had less impact, No
|
11 participants
|
51 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Change in hair color had less impact, NA
|
9 participants
|
20 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Nausea/vomiting had less impact, Yes
|
11 participants
|
32 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Nausea/vomiting had less impact, No
|
7 participants
|
30 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Diarrhea had less impact, Yes
|
16 participants
|
21 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Diarrhea had less impact, No
|
5 participants
|
44 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Pain in stomach area had less impact, Yes
|
9 participants
|
23 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Pain in stomach area had less impact, NA
|
12 participants
|
27 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Changes in food tastes had less impact, No
|
14 participants
|
23 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Changes in food tastes had less impact, NA
|
6 participants
|
12 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Quality of life better, No
|
6 participants
|
12 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Quality of life better, NA
|
4 participants
|
2 participants
|
|
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
Other, NA
|
20 participants
|
66 participants
|
SECONDARY outcome
Timeframe: Day 1 (Period [P] 1 Pre-dose); Weeks 2, 4, 6, 8, and 10 of P 1; during 2-week Wash-out Period (Study Weeks 11 and 12); Weeks 2, 4, 6, and 8 of P 2 (Study Weeks 14, 16, 18, 20, and 22, respectively); End of Study (Week 10 of P 2 [Study Week 22])Population: Safety-Randomized Study Population: participants who received at least one dose of either drug regardless of treatment period. Participants who received mixed treatment within a period were excluded. Only those participants contributing data at the indicated time points were evaluated.
Change from period (P) BL is computed as participants' (par.) average post-BL fatigue score within each P minus their P-specific BL score. P 1 BL is the P 1 Pre-Dose assessment; P 2 BL is the wash-out assessment. Crossover analyses compared par. average scores on each treatment, adjusting for sequence. FACIT-Fatigue Scale: overall score (0 to 52)=the sum of scores for 13 questions. For each question, par. rated their condition for the past week on a 5-point scale: 0 (not at all) to 4 (very much). A high score indicates low fatigue. A negative change from BL represents a worsening of condition.
Outcome measures
| Measure |
Sunitinib 50 mg Followed by Pazopanib 800 mg
n=77 Participants
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Pazopanib 800 mg Followed by Sunitinib 50 mg
n=79 Participants
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
|---|---|---|
|
Change From Period Baseline (BL) in Fatigue as Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
Period 1 Average; n=77, 79
|
-4.4 Scores on a scale
Standard Deviation 7.73
|
-4.6 Scores on a scale
Standard Deviation 9.22
|
|
Change From Period Baseline (BL) in Fatigue as Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
Period 2 Average; n=63, 65
|
-3.6 Scores on a scale
Standard Deviation 7.11
|
-7.3 Scores on a scale
Standard Deviation 11.16
|
SECONDARY outcome
Timeframe: Day 1 (Period 1 Pre-dose); during 2-week Wash-out Period (Study Weeks 11 and 12); and End of Study (Week 10 of Period 2 [Study Week 22])Population: Safety-Randomized Study Population. Participants (par.) who received mixed treatment within a period were excluded. Only those par. contributing data at the indicated time points were evaluated. In some instances, par. may have contributed data for one score, but not the other; thus, the number of par. analyzed reflects the entire population.
The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Outcome measures
| Measure |
Sunitinib 50 mg Followed by Pazopanib 800 mg
n=80 Participants
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Pazopanib 800 mg Followed by Sunitinib 50 mg
n=86 Participants
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
|---|---|---|
|
Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores
Thermometer Score, Day 1; n=74, 79
|
75.7 Scores on a scale
Standard Deviation 17.65
|
74.8 Scores on a scale
Standard Deviation 18.54
|
|
Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores
Thermometer Score, Washout; n=60, 63
|
74.4 Scores on a scale
Standard Deviation 16.76
|
69.8 Scores on a scale
Standard Deviation 19.94
|
|
Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores
Thermometer Score, End of Study; n=51, 45
|
71.3 Scores on a scale
Standard Deviation 16.19
|
65.1 Scores on a scale
Standard Deviation 22.55
|
|
Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores
Utility Score, Day 1; n=76, 81
|
0.7625 Scores on a scale
Standard Deviation 0.25331
|
0.7664 Scores on a scale
Standard Deviation 0.22946
|
|
Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores
Utility Score, Washout; n=61, 67
|
0.8103 Scores on a scale
Standard Deviation 0.20776
|
0.7595 Scores on a scale
Standard Deviation 0.26826
|
|
Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores
Utility Score, End of Study; n=52, 47
|
0.7487 Scores on a scale
Standard Deviation 0.21324
|
0.6325 Scores on a scale
Standard Deviation 0.29635
|
SECONDARY outcome
Timeframe: End of second treatment period (maximum of 22 weeks)Population: Safety-Randomized Study Population. Only those participants who had a dose modification were evaluated.
For the subset of participants who had a dose modification, time to dose modification was defined as the time from the first dose in each period until the first reduction in dose within a period.
Outcome measures
| Measure |
Sunitinib 50 mg Followed by Pazopanib 800 mg
n=30 Participants
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Pazopanib 800 mg Followed by Sunitinib 50 mg
n=20 Participants
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
|---|---|---|
|
Time to Dose Modification
|
3.7 weeks
Interval 2.7 to 5.9
|
4.0 weeks
Interval 2.1 to 6.0
|
SECONDARY outcome
Timeframe: End of second treatment period (maximum of 22 weeks)Population: Safety-Randomized Study Population. Only those participants who had an dose reduction were evaluated.
Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.
Outcome measures
| Measure |
Sunitinib 50 mg Followed by Pazopanib 800 mg
n=30 Participants
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Pazopanib 800 mg Followed by Sunitinib 50 mg
n=20 Participants
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
|---|---|---|
|
Number of Participants With the Indicated Number of Dose Reductions
1
|
16 participants
|
8 participants
|
|
Number of Participants With the Indicated Number of Dose Reductions
2
|
10 participants
|
11 participants
|
|
Number of Participants With the Indicated Number of Dose Reductions
3 or more
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: End of second treatment period (maximum of 22 weeks)Population: Safety-Randomized Study Population. Only those participants who had an dose reduction were evaluated. Participants may be counted multiple times for the same "reason" for a dose reduction if the participant had multiple reductions for the same reason.
Dose reduction of study drug was a stepwise reduction of the dose of the study drug: one less capsule was received at each step reduction. Participants were monitored for approximately 10 to 14 days at each dose level. Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.
Outcome measures
| Measure |
Sunitinib 50 mg Followed by Pazopanib 800 mg
n=30 Participants
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Pazopanib 800 mg Followed by Sunitinib 50 mg
n=20 Participants
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
|---|---|---|
|
Number of Participants With the Indicated Reason for Receiving a Dose Reduction
Other
|
3 participants
|
0 participants
|
|
Number of Participants With the Indicated Reason for Receiving a Dose Reduction
Adverse Event
|
46 participants
|
33 participants
|
SECONDARY outcome
Timeframe: Baseline to end of study (maximum of 22 weeks)Population: Safety-Randomized Study Population
AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.
Outcome measures
| Measure |
Sunitinib 50 mg Followed by Pazopanib 800 mg
n=148 Participants
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Pazopanib 800 mg Followed by Sunitinib 50 mg
n=153 Participants
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
|---|---|---|
|
Number of Participants With Grade 1 to Grade 5 Adverse Events (AEs)
Grade 0
|
0 participants
|
0 participants
|
|
Number of Participants With Grade 1 to Grade 5 Adverse Events (AEs)
Grade 1
|
20 participants
|
25 participants
|
|
Number of Participants With Grade 1 to Grade 5 Adverse Events (AEs)
Grade 2
|
57 participants
|
63 participants
|
|
Number of Participants With Grade 1 to Grade 5 Adverse Events (AEs)
Grade 5
|
1 participants
|
0 participants
|
|
Number of Participants With Grade 1 to Grade 5 Adverse Events (AEs)
Grade 4
|
11 participants
|
8 participants
|
|
Number of Participants With Grade 1 to Grade 5 Adverse Events (AEs)
Grade 3
|
58 participants
|
51 participants
|
SECONDARY outcome
Timeframe: Baseline to end of study (maximum of 22 weeks)Population: Safety-Randomized Study Population. Only those participants with adverse events leading to permanent discontinuation of study treatment were evaluated.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE that spans more than one period is considered to be an AE for each period during which the AE increased in grade. There is only one action with respect to study drug recorded for the whole event. As such, it is not always possible to determine in which study period treatment was discontinued due to the AE.
Outcome measures
| Measure |
Sunitinib 50 mg Followed by Pazopanib 800 mg
n=38 Participants
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Pazopanib 800 mg Followed by Sunitinib 50 mg
n=25 Participants
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
|---|---|---|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Fatigue
|
5 participants
|
3 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Thrombocytopenia
|
3 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Asthenia
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Back pain
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Hypertension
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Nasal congestion
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Pleural effusion
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Transient ischaemic attack
|
0 participants
|
2 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Atrial flutter
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Blood potassium decreased
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Cardiac disorder
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Cardiac failure
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Cough
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Infection
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Infectious peritonitis
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Influenza
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Mucosal inflammation
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Ovarian cyst
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Pain in extremity
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Alanine aminotransferase increased
|
2 participants
|
4 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Vomiting
|
1 participants
|
3 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Aspartate aminotransferase increased
|
0 participants
|
3 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Diarrhoea
|
1 participants
|
2 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Acute myocardial infarction
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Dyspnoea
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Epistaxis
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Decreased appetite
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Dizziness
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Dysgeusia
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Haematemesis
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Haematoma
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Haematuria
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Haemorrhage intracranial
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Headache
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Hepatic function abnormal
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Hepatotoxicity
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Influenza like illness
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Myocardial ischaemia
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Nausea
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Neutropenic infection
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Palmar-plantar erythrodysaesthesia syndrome
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Pancytopenia
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Proteinuria
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Pyrexia
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Rash
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Renal failure
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Respiratory failure
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Sinusitis
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Skin ulcer
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Spinal cord compression
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Stomatitis
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Tooth infection
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Transaminases increased
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Urine protein/creatinine ratio decreased
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment
Weight decreased
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)Population: Safety-Randomized Study Population. All participants who received sunitinib or pazopanib either during Period 1 or Period 2 were counted in both treatment groups (sunitinib and pazopanib). Only those participants contributing data at the indicated time points were evaluated.
When the heart beats, it contracts and pushes blood through the arteries to the rest of body. This force creates pressure on the arteries called SBP. DBP is the pressure in the arteries when the heart rests between beats. Normal levels: SBP (120 mmHg or less); DBP (80 mmHg or less). Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.
Outcome measures
| Measure |
Sunitinib 50 mg Followed by Pazopanib 800 mg
n=139 Participants
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Pazopanib 800 mg Followed by Sunitinib 50 mg
n=147 Participants
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
|---|---|---|
|
Change From Baseline (BL) in Systolic Blood Pressure (SBP) and Diastolic BP (DBP)
SBP, Week 10; n=61, 64
|
4.5 Millimeters of mercury (mmHg)
Standard Deviation 18.43
|
4.7 Millimeters of mercury (mmHg)
Standard Deviation 20.45
|
|
Change From Baseline (BL) in Systolic Blood Pressure (SBP) and Diastolic BP (DBP)
SBP, Week 2; n=139, 147
|
6.3 Millimeters of mercury (mmHg)
Standard Deviation 15.26
|
7.5 Millimeters of mercury (mmHg)
Standard Deviation 16.36
|
|
Change From Baseline (BL) in Systolic Blood Pressure (SBP) and Diastolic BP (DBP)
SBP, Week 6; n=109, 134
|
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 18.65
|
7.5 Millimeters of mercury (mmHg)
Standard Deviation 17.21
|
|
Change From Baseline (BL) in Systolic Blood Pressure (SBP) and Diastolic BP (DBP)
DBP, Week 2; n=139, 147
|
6.5 Millimeters of mercury (mmHg)
Standard Deviation 9.91
|
6.5 Millimeters of mercury (mmHg)
Standard Deviation 10.49
|
|
Change From Baseline (BL) in Systolic Blood Pressure (SBP) and Diastolic BP (DBP)
DBP, Week 6; n=109, 134
|
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 9.48
|
6.9 Millimeters of mercury (mmHg)
Standard Deviation 10.87
|
|
Change From Baseline (BL) in Systolic Blood Pressure (SBP) and Diastolic BP (DBP)
DBP, Week 10; n=61, 64
|
3.1 Millimeters of mercury (mmHg)
Standard Deviation 10.69
|
5.6 Millimeters of mercury (mmHg)
Standard Deviation 11.44
|
SECONDARY outcome
Timeframe: Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)Population: Safety-Randomized Study Population. All participants who received sunitinib or pazopanib either during Period 1 or Period 2 were counted in both treatment groups (sunitinib and pazopanib). Only those participants contributing data at the indicated time points were evaluated.
Heart rate (HR) is the number of heartbeats per unit of time, typically expressed as beats per minute. HR can vary as the body's need to absorb oxygen and excrete carbon dioxide changes, such as during exercise or sleep. A normal resting HR ranges from 60 to 100 beats per minute. Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.
Outcome measures
| Measure |
Sunitinib 50 mg Followed by Pazopanib 800 mg
n=137 Participants
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
Pazopanib 800 mg Followed by Sunitinib 50 mg
n=145 Participants
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
|
|---|---|---|
|
Change From Baseline (BL) in Heart Rate
Week 2, n=137, 145
|
-3.1 Beats per minute
Standard Deviation 12.39
|
-2.7 Beats per minute
Standard Deviation 13.09
|
|
Change From Baseline (BL) in Heart Rate
Week 6, n=106, 131
|
0.8 Beats per minute
Standard Deviation 11.43
|
-3.3 Beats per minute
Standard Deviation 12.41
|
|
Change From Baseline (BL) in Heart Rate
Week 10, n=60, 64
|
-3.8 Beats per minute
Standard Deviation 13.54
|
-1.8 Beats per minute
Standard Deviation 13.84
|
Adverse Events
Sunitinib
Serious events: 35 serious events
Other events: 143 other events
Deaths: 0 deaths
Pazopanib
Serious events: 30 serious events
Other events: 142 other events
Deaths: 0 deaths
Open Label Pazopanib
Serious events: 15 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sunitinib
n=148 participants at risk
Sunitinib
|
Pazopanib
n=153 participants at risk
Pazopanib
|
Open Label Pazopanib
n=84 participants at risk
Open Label Pazopanib
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
3/148
|
1.3%
2/153
|
2.4%
2/84
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
3/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Cardiac disorders
Acute myocardial infarction
|
0.68%
1/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Eye disorders
Retinal detachment
|
0.00%
0/148
|
0.65%
1/153
|
1.2%
1/84
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.4%
2/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Gastrointestinal disorders
Stomatitis
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Gastrointestinal disorders
Vomiting
|
0.68%
1/148
|
0.65%
1/153
|
0.00%
0/84
|
|
General disorders
Asthenia
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
General disorders
Fatigue
|
2.0%
3/148
|
1.3%
2/153
|
1.2%
1/84
|
|
General disorders
General physical health deterioration
|
2.0%
3/148
|
0.00%
0/153
|
0.00%
0/84
|
|
General disorders
Mucosal inflammation
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
General disorders
Oedema
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
General disorders
Oedema peripheral
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
General disorders
Performance status decreased
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
General disorders
Pyrexia
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Infections and infestations
Infection
|
1.4%
2/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Infections and infestations
Lung infection
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Infections and infestations
Neutropenic infection
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Infections and infestations
Oral candidiasis
|
0.68%
1/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Infections and infestations
Peritonitis
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Infections and infestations
Pneumonia
|
0.00%
0/148
|
0.65%
1/153
|
1.2%
1/84
|
|
Infections and infestations
Sepsis
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Infections and infestations
Sinusitis
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Infections and infestations
Urinary tract infection
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
2/148
|
2.0%
3/153
|
1.2%
1/84
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/148
|
1.3%
2/153
|
1.2%
1/84
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Investigations
Lipase abnormal
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.68%
1/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/148
|
0.65%
1/153
|
1.2%
1/84
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Nervous system disorders
Dizziness
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Nervous system disorders
Epilepsy
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Nervous system disorders
Hemiparesis
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Nervous system disorders
Sciatica
|
0.00%
0/148
|
0.00%
0/153
|
1.2%
1/84
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/148
|
1.3%
2/153
|
0.00%
0/84
|
|
Psychiatric disorders
Disorientation
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Renal and urinary disorders
Haematuria
|
1.4%
2/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
2/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
2/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/148
|
0.65%
1/153
|
0.00%
0/84
|
|
Vascular disorders
Haematoma
|
0.68%
1/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Vascular disorders
Hypertension
|
1.4%
2/148
|
2.0%
3/153
|
0.00%
0/84
|
Other adverse events
| Measure |
Sunitinib
n=148 participants at risk
Sunitinib
|
Pazopanib
n=153 participants at risk
Pazopanib
|
Open Label Pazopanib
n=84 participants at risk
Open Label Pazopanib
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.4%
5/148
|
2.6%
4/153
|
6.0%
5/84
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.4%
8/148
|
3.9%
6/153
|
4.8%
4/84
|
|
Endocrine disorders
Hypothyroidism
|
4.1%
6/148
|
3.9%
6/153
|
6.0%
5/84
|
|
Gastrointestinal disorders
Abdominal pain
|
10.8%
16/148
|
13.1%
20/153
|
13.1%
11/84
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.8%
19/148
|
4.6%
7/153
|
9.5%
8/84
|
|
Gastrointestinal disorders
Constipation
|
15.5%
23/148
|
8.5%
13/153
|
11.9%
10/84
|
|
Gastrointestinal disorders
Diarrhoea
|
33.1%
49/148
|
41.2%
63/153
|
53.6%
45/84
|
|
Gastrointestinal disorders
Dyspepsia
|
15.5%
23/148
|
11.1%
17/153
|
7.1%
6/84
|
|
Gastrointestinal disorders
Flatulence
|
3.4%
5/148
|
6.5%
10/153
|
6.0%
5/84
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.8%
10/148
|
2.0%
3/153
|
1.2%
1/84
|
|
Gastrointestinal disorders
Nausea
|
31.1%
46/148
|
32.7%
50/153
|
31.0%
26/84
|
|
Gastrointestinal disorders
Stomatitis
|
14.9%
22/148
|
4.6%
7/153
|
6.0%
5/84
|
|
Gastrointestinal disorders
Vomiting
|
17.6%
26/148
|
13.7%
21/153
|
21.4%
18/84
|
|
General disorders
Asthenia
|
23.6%
35/148
|
17.0%
26/153
|
19.0%
16/84
|
|
General disorders
Fatigue
|
28.4%
42/148
|
28.1%
43/153
|
29.8%
25/84
|
|
General disorders
Mucosal inflammation
|
21.6%
32/148
|
16.3%
25/153
|
7.1%
6/84
|
|
General disorders
Pyrexia
|
6.8%
10/148
|
3.3%
5/153
|
1.2%
1/84
|
|
Hepatobiliary disorders
Jaundice
|
5.4%
8/148
|
0.00%
0/153
|
0.00%
0/84
|
|
Infections and infestations
Bronchitis
|
0.00%
0/148
|
0.00%
0/153
|
6.0%
5/84
|
|
Infections and infestations
Lower respiratory tract infection
|
1.4%
2/148
|
0.00%
0/153
|
7.1%
6/84
|
|
Infections and infestations
Urinary tract infection
|
2.7%
4/148
|
3.3%
5/153
|
6.0%
5/84
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
5/148
|
5.9%
9/153
|
8.3%
7/84
|
|
Investigations
Blood creatinine increased
|
3.4%
5/148
|
1.3%
2/153
|
6.0%
5/84
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.4%
2/148
|
0.00%
0/153
|
6.0%
5/84
|
|
Investigations
Weight decreased
|
4.7%
7/148
|
5.9%
9/153
|
10.7%
9/84
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.3%
30/148
|
20.9%
32/153
|
21.4%
18/84
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
5/148
|
7.2%
11/153
|
7.1%
6/84
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
9/148
|
8.5%
13/153
|
4.8%
4/84
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.1%
6/148
|
5.9%
9/153
|
7.1%
6/84
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
5/148
|
3.3%
5/153
|
6.0%
5/84
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.8%
10/148
|
5.9%
9/153
|
2.4%
2/84
|
|
Nervous system disorders
Dysgeusia
|
27.0%
40/148
|
16.3%
25/153
|
14.3%
12/84
|
|
Nervous system disorders
Headache
|
11.5%
17/148
|
14.4%
22/153
|
8.3%
7/84
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
10/148
|
3.9%
6/153
|
6.0%
5/84
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.4%
2/148
|
4.6%
7/153
|
7.1%
6/84
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.7%
7/148
|
7.8%
12/153
|
7.1%
6/84
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.1%
15/148
|
5.2%
8/153
|
8.3%
7/84
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.1%
6/148
|
7.2%
11/153
|
7.1%
6/84
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.5%
14/148
|
3.9%
6/153
|
7.1%
6/84
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.4%
5/148
|
5.2%
8/153
|
3.6%
3/84
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
12.8%
19/148
|
17.0%
26/153
|
10.7%
9/84
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
26.4%
39/148
|
17.6%
27/153
|
13.1%
11/84
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.5%
17/148
|
8.5%
13/153
|
11.9%
10/84
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
4.1%
6/148
|
5.2%
8/153
|
1.2%
1/84
|
|
Vascular disorders
Hypertension
|
25.0%
37/148
|
20.9%
32/153
|
15.5%
13/84
|
Additional Information
Clinical Disclosure Office
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER