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Trial record 14 of 73 for:    inflammatory breast cancer AND Complete Response

Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer

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ClinicalTrials.gov Identifier: NCT00558103
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : July 18, 2012
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Neoplasms, Breast
Interventions Drug: lapatinib
Drug: Pazopanib
Enrollment 163

Recruitment Details This study consisted of an initial randomized treatment phase; participants were randomized to receive lapatinib, pazopanib, or combination therapy. Participants who received pazopanib monotherapy in this initial phase and experienced disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
Pre-assignment Details Enrollment in Cohort 1 was halted after 76 participants had been randomized based on safety data from Study VEG20007 (NCT00347919). The protocol was amended (Amendment 2) to change the combination therapy dose (Cohort 2); in addition, an open-label pazopanib arm (pazopanib 800 milligrams) was added (Cohort 2).
Arm/Group Title Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo Cohort 2: Pazopanib 800 mg Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg Open-label Lapatinib 1500 mg
Hide Arm/Group Description Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD). Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD. Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase. Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib 800 mg in the randomized treatment phase were given the option to receive oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) QD.
Period Title: Randomized Treatment Phase
Started 38 38 36 13 38 0
Completed 33 34 33 11 33 0
Not Completed 5 4 3 2 5 0
Reason Not Completed
Lost to Follow-up             2             2             2             1             3             0
Withdrawal by Subject             2             2             0             0             1             0
Disease Progression             1             0             1             0             0             0
Adverse Event             0             0             0             1             1             0
Period Title: Monotherapy Extension Phase
Started 0 0 0 0 0 9 [1]
Completed 0 0 0 0 0 0
Not Completed 0 0 0 0 0 9
Reason Not Completed
Protocol Violation             0             0             0             0             0             1
Disease Progression             0             0             0             0             0             8
[1]
9/11 participants completing pazopanib monotherapy elected to receive lapatinib monotherapy.
Arm/Group Title Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo Cohort 2: Pazopanib 800 mg Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg Total
Hide Arm/Group Description Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD). Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD. Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase. Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Total of all reporting groups
Overall Number of Baseline Participants 38 38 36 13 38 163
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Years Number Analyzed 38 participants 38 participants 36 participants 13 participants 38 participants 163 participants
51.9  (9.00) 52.4  (12.84) 53.0  (10.39) 54.7  (12.26) 53.9  (12.65) 53.0  (11.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 38 participants 36 participants 13 participants 38 participants 163 participants
Female
38
 100.0%
38
 100.0%
36
 100.0%
13
 100.0%
38
 100.0%
163
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants 38 participants 36 participants 13 participants 38 participants 163 participants
African American/African Heritage 1 1 0 0 0 2
American Indian or Alaska Native 1 3 2 1 3 10
Central/South Asian Heritage 2 1 2 1 2 8
Japanese/East Asian /South East Asian Heritage 9 6 11 5 14 45
White 24 27 21 6 19 97
American Indian or Alaska Native and Asian 1 0 0 0 0 1
1.Primary Outcome
Title Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions
Hide Description RECIST-based response assessment was done at Weeks (Wks) 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, CR is the disappearance of all target and non-target lesions; PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.
Time Frame Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least one dose of study treatment. The mITT1 Population was used for cohort 1; the mITT2 Population used for cohort 2.
Arm/Group Title Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo Cohort 2: Pazopanib 800 mg Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg
Hide Arm/Group Description:
Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 38 38 36 13 38
Measure Type: Number
Unit of Measure: participants
11 17 17 4 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 29
Confidence Interval (2-Sided) 90%
17.2 to 43.3
Estimation Comments The estimated value represents the percentage of participants with CR and PR.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 45
Confidence Interval (2-Sided) 90%
30.9 to 59.3
Estimation Comments The estimated value represents the percentage of participants with CR and PR.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparision of participants receiving lapatanib 1500 mg + placebo to historical control of 10% response rate
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 47
Confidence Interval (2-Sided) 90%
32.8 to 62.1
Estimation Comments The estimated value represents the percentage of participants receiving lapatanib 1500 mg + placebo with CR and PR.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort 2: Pazopanib 800 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 31
Confidence Interval (2-Sided) 90%
11.3 to 57.3
Estimation Comments The estimated value represents the percentage of participants with CR and PR.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparision of participants receiving lapatanib 1000 mg + pazopanib 400 mg to 10% historical response rate
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 58
Confidence Interval (2-Sided) 90%
43.3 to 71.5
Estimation Comments The estimated value represents the percentage of participants receiving lapatanib 1000 mg + pazopanib 400 mg with CR and PR.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo, Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.485
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 11
Confidence Interval (2-Sided) 90%
-8.3 to 29.7
Estimation Comments The estimated value represents the percent difference in the percentage of participants with CR and PR.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Cohort 2: Pazopanib 800 mg, Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.116
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage of participants
Estimated Value 27
Confidence Interval (2-Sided) 90%
2.3 to 52.0
Estimation Comments The estimated value represents the percent difference in the percentage of participants with CR and PR.
2.Secondary Outcome
Title Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression
Hide Description RECIST-based response assessment was done at Wks 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, PD is >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.
Time Frame From the date of the first documented evidence of CR or PR until the date of the first documented disease progression or death, assessed for up to 62 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT1 and mITT2 Populations. Only participants who achieved a response of CR or PR during the study were analyzed. For participants who did not progress or die, duration of response was censored on the date of the last adequate assessment.
Arm/Group Title Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo Cohort 2: Pazopanib 800 mg Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg
Hide Arm/Group Description:
Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 11 17 17 4 22
Median (90% Confidence Interval)
Unit of Measure: weeks
16.9
(12.4 to 21.0)
13.0
(9.1 to 28.1)
13.6
(10.0 to 19.9)
31.2
(3.4 to 33.1)
12.7
(8.0 to 16.1)
3.Secondary Outcome
Title Progression-free Survival, Defined as the Interval Between the Date of Randomization and the Earliest Date of Disease Progression (PD) or Death Due to Any Cause (Defined by an Investigator Review of Lesions Based on RECIST and Cutaneous Disease)
Hide Description RECIST-based response assessment was done at Wks 4 and 8 and every 8 weeks thereafter. Cutaneous disease assessment was done at Wk 4 and every 4 weeks thereafter. OR was evaluated when the skin and RECIST assessments coincided. Per RECIST, PD is >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions. Cutaneous disease contained non-measurable and measurable skin disease, which was assessed by skin assessment tools.
Time Frame From the date of the randomization until the earliest date of disease progression or death due to any cause, assessed for up to 66 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT1 and mITT2 Populations
Arm/Group Title Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo Cohort 2: Pazopanib 800 mg Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg
Hide Arm/Group Description:
Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 38 38 36 13 38
Median (90% Confidence Interval)
Unit of Measure: weeks
16.1
(12.0 to 21.1)
14.3
(8.6 to 20.1)
16.0
(12.4 to 16.3)
11.4
(6.6 to 33.6)
16.0
(12.4 to 17.9)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from randomization until death due to any cause. For participants who did not die, time to death was censored at the time of last contact.
Time Frame From the date of randomization until the date of death due to any cause, assessed for up to 163 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT1 and mITT2 Populations
Arm/Group Title Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo Cohort 2: Pazopanib 800 mg Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg
Hide Arm/Group Description:
Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 38 38 36 13 38
Median (90% Confidence Interval)
Unit of Measure: months
14.7
(12.1 to 16.5)
16.2
(12.7 to 21.1)
15.9 [1] 
(13.4 to NA)
NA [2] 
(9.8 to NA)
NA [2] 
(12.4 to NA)
[1]
Due to an insufficient number of events, the upper limit of the confidence interval could not be calculated.
[2]
Due to an insufficient number of events, the median and the upper limit of the confidence interval could not be calculated.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo Cohort 2: Pazopanib 800 mg Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg Open-label Lapatinib 1500 mg
Hide Arm/Group Description Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD). Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD. Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase. Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib 800 mg in the randomized treatment phase were given the option to receive oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) QD.
All-Cause Mortality
Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo Cohort 2: Pazopanib 800 mg Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg Open-label Lapatinib 1500 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo Cohort 2: Pazopanib 800 mg Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg Open-label Lapatinib 1500 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/38 (15.79%)   14/38 (36.84%)   4/36 (11.11%)   4/13 (30.77%)   9/38 (23.68%)   0/9 (0.00%) 
Blood and lymphatic system disorders             
Neutropenia  1  1/38 (2.63%)  1/38 (2.63%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Cardiac disorders             
Sinus tachycardia  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Bradycardia  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Cardiopulmonary failure  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Gastrointestinal disorders             
Vomiting  1  1/38 (2.63%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Diarrhea  1  0/38 (0.00%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Nausea  1  1/38 (2.63%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Abdominal pain  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  1/38 (2.63%)  0/9 (0.00%) 
Pancreatitis  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
General disorders             
Sudden death  1  1/38 (2.63%)  1/38 (2.63%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Fatigue  1  0/38 (0.00%)  0/38 (0.00%)  1/36 (2.78%)  1/13 (7.69%)  1/38 (2.63%)  0/9 (0.00%) 
Asthenia  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Hepatobiliary disorders             
Hepatotoxicity  1  0/38 (0.00%)  1/38 (2.63%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Cholestatic liver injury  1  1/38 (2.63%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Hepatic function abnormal  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Infections and infestations             
Empyema  1  0/38 (0.00%)  1/38 (2.63%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Sepsis  1  0/38 (0.00%)  1/38 (2.63%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Upper respiratory tract infection  1  1/38 (2.63%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Pneumonia  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  1/38 (2.63%)  0/9 (0.00%) 
Injury, poisoning and procedural complications             
Eye injury  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Investigations             
Alanine aminotransferase increased  1  0/38 (0.00%)  1/38 (2.63%)  1/36 (2.78%)  0/13 (0.00%)  3/38 (7.89%)  0/9 (0.00%) 
Ejection fraction decreased  1  0/38 (0.00%)  1/38 (2.63%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Liver function test abnormal  1  0/38 (0.00%)  1/38 (2.63%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Blood bilirubin increased  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Gamma-glutamyltransferase increased  1  0/38 (0.00%)  0/38 (0.00%)  1/36 (2.78%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Metabolism and nutrition disorders             
Hyperuricemia  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back pain  1  0/38 (0.00%)  1/38 (2.63%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Musculoskeletal chest pain  1  0/38 (0.00%)  1/38 (2.63%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Metastases to peritoneum  1  0/38 (0.00%)  0/38 (0.00%)  1/36 (2.78%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Nervous system disorders             
Headache  1  0/38 (0.00%)  1/38 (2.63%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Subarachnoid hemorrhage  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Pulmonary embolism  1  0/38 (0.00%)  1/38 (2.63%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Respiratory failure  1  0/38 (0.00%)  1/38 (2.63%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Pleurisy  1  1/38 (2.63%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Dyspnea  1  0/38 (0.00%)  0/38 (0.00%)  1/36 (2.78%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Hypoxia  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Pleural effusion  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Orthopnea  1  0/38 (0.00%)  0/38 (0.00%)  1/36 (2.78%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Pulmonary edema  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders             
Skin hemorrhage  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Skin ulcer  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Vascular disorders             
Hypertension  1  0/38 (0.00%)  1/38 (2.63%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo Cohort 2: Pazopanib 800 mg Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg Open-label Lapatinib 1500 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/38 (81.58%)   37/38 (97.37%)   34/36 (94.44%)   13/13 (100.00%)   35/38 (92.11%)   7/9 (77.78%) 
Blood and lymphatic system disorders             
Neutropenia  1  0/38 (0.00%)  5/38 (13.16%)  0/36 (0.00%)  4/13 (30.77%)  7/38 (18.42%)  0/9 (0.00%) 
Anemia  1  2/38 (5.26%)  2/38 (5.26%)  4/36 (11.11%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Leukopenia  1  0/38 (0.00%)  2/38 (5.26%)  2/36 (5.56%)  1/13 (7.69%)  8/38 (21.05%)  1/9 (11.11%) 
Thrombocytopenia  1  0/38 (0.00%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Ear and labyrinth disorders             
Tinnitus  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  2/38 (5.26%)  0/9 (0.00%) 
Endocrine disorders             
Hypothyroidism  1  1/38 (2.63%)  2/38 (5.26%)  0/36 (0.00%)  2/13 (15.38%)  4/38 (10.53%)  0/9 (0.00%) 
Eye disorders             
Dry eye  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  2/38 (5.26%)  0/9 (0.00%) 
Lacrimation increased  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  1/9 (11.11%) 
Ocular hyperaemia  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  1/9 (11.11%) 
Gastrointestinal disorders             
Diarrhea  1  15/38 (39.47%)  33/38 (86.84%)  20/36 (55.56%)  6/13 (46.15%)  22/38 (57.89%)  2/9 (22.22%) 
Nausea  1  5/38 (13.16%)  17/38 (44.74%)  6/36 (16.67%)  2/13 (15.38%)  9/38 (23.68%)  2/9 (22.22%) 
Vomiting  1  6/38 (15.79%)  15/38 (39.47%)  2/36 (5.56%)  4/13 (30.77%)  5/38 (13.16%)  1/9 (11.11%) 
Abdominal pain upper  1  2/38 (5.26%)  4/38 (10.53%)  2/36 (5.56%)  0/13 (0.00%)  2/38 (5.26%)  0/9 (0.00%) 
Stomatitis  1  2/38 (5.26%)  4/38 (10.53%)  0/36 (0.00%)  1/13 (7.69%)  2/38 (5.26%)  0/9 (0.00%) 
Abdominal pain  1  0/38 (0.00%)  3/38 (7.89%)  2/36 (5.56%)  2/13 (15.38%)  7/38 (18.42%)  0/9 (0.00%) 
Dyspepsia  1  0/38 (0.00%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Constipation  1  2/38 (5.26%)  0/38 (0.00%)  3/36 (8.33%)  1/13 (7.69%)  1/38 (2.63%)  1/9 (11.11%) 
Mouth ulceration  1  0/38 (0.00%)  0/38 (0.00%)  2/36 (5.56%)  1/13 (7.69%)  2/38 (5.26%)  0/9 (0.00%) 
Dry mouth  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  2/38 (5.26%)  0/9 (0.00%) 
Abdominal discomfort  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Abdominal distension  1  0/38 (0.00%)  0/38 (0.00%)  2/36 (5.56%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
General disorders             
Fatigue  1  4/38 (10.53%)  14/38 (36.84%)  6/36 (16.67%)  3/13 (23.08%)  8/38 (21.05%)  0/9 (0.00%) 
Asthenia  1  4/38 (10.53%)  8/38 (21.05%)  1/36 (2.78%)  0/13 (0.00%)  4/38 (10.53%)  1/9 (11.11%) 
Mucosal inflammation  1  0/38 (0.00%)  6/38 (15.79%)  1/36 (2.78%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Pyrexia  1  2/38 (5.26%)  3/38 (7.89%)  1/36 (2.78%)  0/13 (0.00%)  3/38 (7.89%)  0/9 (0.00%) 
Hyperthermia  1  2/38 (5.26%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Malaise  1  0/38 (0.00%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Edema peripheral  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  2/38 (5.26%)  0/9 (0.00%) 
Hepatobiliary disorders             
Hyperbilirubinemia  1  2/38 (5.26%)  7/38 (18.42%)  0/36 (0.00%)  1/13 (7.69%)  1/38 (2.63%)  0/9 (0.00%) 
Jaundice  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Infections and infestations             
Urinary tract infection  1  3/38 (7.89%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Nasopharyngitis  1  0/38 (0.00%)  0/38 (0.00%)  2/36 (5.56%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Staphylococcal skin infection  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  1/9 (11.11%) 
Injury, poisoning and procedural complications             
Chemical eye injury  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  1/9 (11.11%) 
Investigations             
Aspartate aminotransferase increased  1  5/38 (13.16%)  13/38 (34.21%)  8/36 (22.22%)  3/13 (23.08%)  10/38 (26.32%)  1/9 (11.11%) 
Alanine aminotransferase increased  1  4/38 (10.53%)  13/38 (34.21%)  8/36 (22.22%)  2/13 (15.38%)  8/38 (21.05%)  1/9 (11.11%) 
Weight decreased  1  1/38 (2.63%)  5/38 (13.16%)  2/36 (5.56%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Blood bilirubin increased  1  0/38 (0.00%)  5/38 (13.16%)  5/36 (13.89%)  1/13 (7.69%)  6/38 (15.79%)  0/9 (0.00%) 
Blood lactate dehydrogenase increased  1  0/38 (0.00%)  5/38 (13.16%)  0/36 (0.00%)  2/13 (15.38%)  4/38 (10.53%)  0/9 (0.00%) 
Blood alkaline phosphatase increased  1  2/38 (5.26%)  3/38 (7.89%)  3/36 (8.33%)  2/13 (15.38%)  4/38 (10.53%)  0/9 (0.00%) 
Blood pressure increased  1  1/38 (2.63%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Blood thyroid stimulating hormone increased  1  0/38 (0.00%)  0/38 (0.00%)  1/36 (2.78%)  2/13 (15.38%)  3/38 (7.89%)  0/9 (0.00%) 
Platelet count decreased  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  2/13 (15.38%)  3/38 (7.89%)  0/9 (0.00%) 
Bilirubin conjugated increased  1  0/38 (0.00%)  0/38 (0.00%)  2/36 (5.56%)  0/13 (0.00%)  2/38 (5.26%)  0/9 (0.00%) 
Blood bicarbonate decreased  1  0/38 (0.00%)  0/38 (0.00%)  3/36 (8.33%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Ejection fraction decreased  1  0/38 (0.00%)  0/38 (0.00%)  1/36 (2.78%)  1/13 (7.69%)  2/38 (5.26%)  0/9 (0.00%) 
Blood sodium decreased  1  0/38 (0.00%)  0/38 (0.00%)  1/36 (2.78%)  1/13 (7.69%)  1/38 (2.63%)  0/9 (0.00%) 
Electrocardiogram QT prolonged  1  0/38 (0.00%)  0/38 (0.00%)  1/36 (2.78%)  0/13 (0.00%)  2/38 (5.26%)  0/9 (0.00%) 
Gamma-glutamyltransferase increased  1  0/38 (0.00%)  0/38 (0.00%)  1/36 (2.78%)  0/13 (0.00%)  2/38 (5.26%)  0/9 (0.00%) 
Hemoglobin decreased  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  3/38 (7.89%)  0/9 (0.00%) 
Electrocardiogram ST segment depression  1  0/38 (0.00%)  0/38 (0.00%)  2/36 (5.56%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Platelet count increased  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  1/9 (11.11%) 
Metabolism and nutrition disorders             
Decreased appetite  1  4/38 (10.53%)  9/38 (23.68%)  3/36 (8.33%)  2/13 (15.38%)  7/38 (18.42%)  1/9 (11.11%) 
Hypokalemia  1  0/38 (0.00%)  0/38 (0.00%)  1/36 (2.78%)  0/13 (0.00%)  2/38 (5.26%)  0/9 (0.00%) 
Enzyme abnormality  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders             
Myalgia  1  1/38 (2.63%)  6/38 (15.79%)  1/36 (2.78%)  1/13 (7.69%)  1/38 (2.63%)  0/9 (0.00%) 
Arthralgia  1  1/38 (2.63%)  3/38 (7.89%)  0/36 (0.00%)  1/13 (7.69%)  1/38 (2.63%)  0/9 (0.00%) 
Back pain  1  2/38 (5.26%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Muscle spasms  1  1/38 (2.63%)  2/38 (5.26%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Musculoskeletal chest pain  1  0/38 (0.00%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Pain in extremity  1  4/38 (10.53%)  1/38 (2.63%)  0/36 (0.00%)  1/13 (7.69%)  2/38 (5.26%)  0/9 (0.00%) 
Clubbing  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Musculoskeletal pain  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Neck pain  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Cancer pain  1  2/38 (5.26%)  2/38 (5.26%)  2/36 (5.56%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Nervous system disorders             
Headache  1  4/38 (10.53%)  7/38 (18.42%)  4/36 (11.11%)  0/13 (0.00%)  3/38 (7.89%)  1/9 (11.11%) 
Dizziness  1  0/38 (0.00%)  2/38 (5.26%)  1/36 (2.78%)  1/13 (7.69%)  6/38 (15.79%)  0/9 (0.00%) 
Dysgeusia  1  0/38 (0.00%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  2/38 (5.26%)  0/9 (0.00%) 
Paraesthesia  1  2/38 (5.26%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Hypoaesthesia  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  2/13 (15.38%)  0/38 (0.00%)  0/9 (0.00%) 
Neuralgia  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  1/9 (11.11%) 
Psychiatric disorders             
Insomnia  1  0/38 (0.00%)  0/38 (0.00%)  2/36 (5.56%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Renal and urinary disorders             
Dysuria  1  0/38 (0.00%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Proteinuria  1  0/38 (0.00%)  2/38 (5.26%)  2/36 (5.56%)  2/13 (15.38%)  4/38 (10.53%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders             
Epistaxis  1  3/38 (7.89%)  5/38 (13.16%)  1/36 (2.78%)  0/13 (0.00%)  3/38 (7.89%)  0/9 (0.00%) 
Dyspnea  1  2/38 (5.26%)  3/38 (7.89%)  1/36 (2.78%)  0/13 (0.00%)  2/38 (5.26%)  0/9 (0.00%) 
Dysphonia  1  0/38 (0.00%)  3/38 (7.89%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Cough  1  2/38 (5.26%)  1/38 (2.63%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Hemoptysis  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  0/9 (0.00%) 
Nasal discomfort  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  1/9 (11.11%) 
Skin and subcutaneous tissue disorders             
Rash  1  5/38 (13.16%)  9/38 (23.68%)  11/36 (30.56%)  0/13 (0.00%)  12/38 (31.58%)  1/9 (11.11%) 
Acne  1  1/38 (2.63%)  5/38 (13.16%)  3/36 (8.33%)  0/13 (0.00%)  1/38 (2.63%)  1/9 (11.11%) 
Alopecia  1  4/38 (10.53%)  3/38 (7.89%)  0/36 (0.00%)  0/13 (0.00%)  3/38 (7.89%)  0/9 (0.00%) 
Erythema  1  3/38 (7.89%)  3/38 (7.89%)  1/36 (2.78%)  1/13 (7.69%)  2/38 (5.26%)  0/9 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  3/38 (7.89%)  3/38 (7.89%)  2/36 (5.56%)  2/13 (15.38%)  2/38 (5.26%)  1/9 (11.11%) 
Dermatitis acneiform  1  2/38 (5.26%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Dry skin  1  2/38 (5.26%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  2/38 (5.26%)  0/9 (0.00%) 
Hair color changes  1  0/38 (0.00%)  2/38 (5.26%)  1/36 (2.78%)  1/13 (7.69%)  6/38 (15.79%)  0/9 (0.00%) 
Pruritis  1  4/38 (10.53%)  1/38 (2.63%)  4/36 (11.11%)  1/13 (7.69%)  3/38 (7.89%)  0/9 (0.00%) 
Rash erythematous  1  2/38 (5.26%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Nail disorder  1  0/38 (0.00%)  0/38 (0.00%)  2/36 (5.56%)  0/13 (0.00%)  1/38 (2.63%)  0/9 (0.00%) 
Skin ulcer  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  2/13 (15.38%)  0/38 (0.00%)  0/9 (0.00%) 
Skin irritation  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  1/13 (7.69%)  0/38 (0.00%)  1/9 (11.11%) 
Scab  1  0/38 (0.00%)  0/38 (0.00%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  1/9 (11.11%) 
Vascular disorders             
Hypertension  1  1/38 (2.63%)  11/38 (28.95%)  1/36 (2.78%)  3/13 (23.08%)  9/38 (23.68%)  0/9 (0.00%) 
Hot flush  1  2/38 (5.26%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Hematoma  1  0/38 (0.00%)  2/38 (5.26%)  0/36 (0.00%)  0/13 (0.00%)  0/38 (0.00%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00558103     History of Changes
Other Study ID Numbers: VEG108838
First Submitted: November 9, 2007
First Posted: November 14, 2007
Results First Submitted: May 17, 2012
Results First Posted: July 18, 2012
Last Update Posted: February 4, 2013