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A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00435409
Recruitment Status : Completed
First Posted : February 15, 2007
Results First Posted : January 13, 2011
Last Update Posted : June 26, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Neoplasms
Interventions Drug: Sunitinib + Capecitabine
Drug: Capecitabine
Enrollment 442
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib + Capecitabine Capecitabine, no Crossover Capecitabine, Crossover to Sunitinib
Hide Arm/Group Description Sunitinib administered orally at a starting dose of 37.5 milligrams (mg) once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 milligrams per square meter (mg/m^2) per day (1000 mg/m^2 twice daily [BID]) from Days 1-14 every 3 weeks. Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
Period Title: Overall Study
Started 221 143 78
Treated 217 139 78
Completed 0 0 0
Not Completed 221 143 78
Reason Not Completed
Protocol Violation             1             2             0
Lost to Follow-up             1             2             0
Death             8             6             6
Objective progression or relapse             158             93             58
Global deterioration of health status             0             0             4
Withdrawal by Subject             8             7             1
Other             45             30             1
Adverse Event             0             0             8
Sponsor decision             0             3             0
Arm/Group Title Sunitinib + Capecitabine Capecitabine Total
Hide Arm/Group Description Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks. Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously. Total of all reporting groups
Overall Number of Baseline Participants 221 221 442
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
Less than 65 years 182 185 367
Greater than or equal to 65 years 39 36 75
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 221 participants 442 participants
Female
218
  98.6%
220
  99.5%
438
  99.1%
Male
3
   1.4%
1
   0.5%
4
   0.9%
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description Defined as the time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date minus randomization date plus 1) divided by 30.4.
Time Frame Baseline until disease progression (up to 3 years from first dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population: defined as all participants who were randomized
Arm/Group Title Sunitinib + Capecitabine Capecitabine
Hide Arm/Group Description:
Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
Overall Number of Participants Analyzed 221 221
Median (95% Confidence Interval)
Unit of Measure: months
Independent radiology assessment
5.5
(4.5 to 6.0)
5.9
(5.4 to 7.6)
Investigator's assessment
5.4
(4.4 to 5.8)
5.5
(4.3 to 6.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib + Capecitabine, Capecitabine
Comments A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9409
Comments Stratification factors included metastatic organ sites (2 or less versus [vs] more than [>] 2 sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs >1), from interactive voice response system (IVRS).
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.2239
Confidence Interval (2-Sided) 95%
0.9487 to 1.5789
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sunitinib + Capecitabine, Capecitabine
Comments A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8120
Comments Stratification factors include metastatic organ sites (2 or less versus [vs] 2 or more sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs more than 1), from IVRS.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.1084
Confidence Interval (2-Sided) 95%
0.8817 to 1.3935
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Objective Response (OR)
Hide Description Proportion of participants with confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST); CR: disappearance of all target lesions, PR: greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD. Confirmed responses = persist on repeat imaging study at least 4 weeks after initial documentation of response. Designation of best response of stable disease (SD) required the criteria to be met at least 5 weeks after randomization.
Time Frame Baseline until response or disease progression (up to 3 years from first dose)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Sunitinib + Capecitabine Capecitabine
Hide Arm/Group Description:
Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
Overall Number of Participants Analyzed 221 221
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Independent radiology assessment
18.6
(13.7 to 24.3)
16.3
(11.7 to 21.8)
Investigator's assessment
25.3
(19.7 to 31.6)
20.4
(15.3 to 26.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib + Capecitabine, Capecitabine
Comments Independent radiology assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3143
Comments A stratified CMH test stratified by randomization stratification factors was used to compare objective response rate (ORR) between two treatment arms.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.69 to 1.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sunitinib + Capecitabine, Capecitabine
Comments Investigator's assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1269
Comments A stratified CMH test stratified by randomization stratification factors was used to compare ORR between two treatment arms.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
0.83 to 2.13
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Duration of Response (DR)
Hide Description Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in months) was calculated as [the date response ended (date of PD or death) minus first CR or PR date that was subsequently confirmed plus 1)] divided by 30.4.
Time Frame Baseline until response or disease progression (up to 3 years from first dose)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT subgroup of participants with a confirmed objective tumor response.
Arm/Group Title Sunitinib + Capecitabine Capecitabine
Hide Arm/Group Description:
Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
Overall Number of Participants Analyzed 41 36
Median (95% Confidence Interval)
Unit of Measure: months
Independent radiology assessment
9.0
(5.7 to 20.7)
8.8
(5.7 to 13.8)
Investigator's assessment
5.7
(4.3 to 6.9)
7.6
(6.5 to 9.9)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description Time from the date of randomization to the date of death due to any cause. OS (in months) calculated as (date of death minus randomization date plus 1) divided by 30.4. For patients lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Patients lacking survival data beyond randomization had their OS times censored at randomization.
Time Frame Baseline until death or up to 3 years from first dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Sunitinib + Capecitabine Capecitabine
Hide Arm/Group Description:
Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
Overall Number of Participants Analyzed 221 221
Median (95% Confidence Interval)
Unit of Measure: months
16.5
(14.5 to 19.6)
17.2
(15.5 to 19.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib + Capecitabine, Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6275
Comments Stratification factors (all from IVRS) included number of metastatic organ sites (<=2 vs >2 sites), hormone receptor status (HER2—/ER—/PR— vs all others), and prior chemotherapy regimens (1 vs >1).
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.0372
Confidence Interval (2-Sided) 95%
0.8322 to 1.2927
Estimation Comments Hazard ratio for sunitinib + capecitabine versus capecitabine.
5.Secondary Outcome
Title Percent Chance of Participant Survival
Hide Description Probability of survival 2 years and 3 years after the first dose of study treatment.
Time Frame Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Sunitinib + Capecitabine Capecitabine
Hide Arm/Group Description:
Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
Overall Number of Participants Analyzed 221 221
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability of survival
Year 1
0.635
(0.567 to 0.696)
0.654
(0.585 to 0.715)
Year 2
0.368
(0.303 to 0.433)
0.373
(0.306 to 0.440)
Year 3
0.150
(0.098 to 0.213)
0.174
(0.115 to 0.243)
6.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire (EORTC QLQ-C30)
Hide Description EORTC QLQ-C30: global health/quality of life (QoL), functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms
Time Frame Day 1 of each treatment cycle (up to 3 years or end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Patient Reported Outcomes (PRO) assessments were not analyzed because the study did not meet its primary endpoint.
Arm/Group Title Sunitinib + Capecitabine Capecitabine
Hide Arm/Group Description:
Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-BR23)
Hide Description BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
Time Frame Day 1 of each treatment cycle (up to 3 years or end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
PRO assessments were not analyzed because the study did not meet its primary endpoint.
Arm/Group Title Sunitinib + Capecitabine Capecitabine
Hide Arm/Group Description:
Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change From Baseline in EuroQol Group's EuroQol 5-Dimensional Self-Report Questionnaire (EQ-5D)
Hide Description EQ-5D: health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities). Three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A single score between 1 and 3 is generated for each domain. For each subject, the outcome rating on the 5 domains could be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.
Time Frame Day 1 of each treatment cycle (up to 3 years or end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
PRO assessments were not analyzed because the study did not meet its primary endpoint.
Arm/Group Title Sunitinib + Capecitabine Capecitabine
Hide Arm/Group Description:
Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Sunitinib + Capecitabine Capecitabine
Hide Arm/Group Description Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks. Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
All-Cause Mortality
Sunitinib + Capecitabine Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Sunitinib + Capecitabine Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   85/217 (39.17%)   59/215 (27.44%) 
Blood and lymphatic system disorders     
Anaemia * 1  7/217 (3.23%)  1/215 (0.47%) 
Bone marrow failure * 1  1/217 (0.46%)  0/215 (0.00%) 
Leukopenia * 1  2/217 (0.92%)  0/215 (0.00%) 
Neutropenia * 1  3/217 (1.38%)  0/215 (0.00%) 
Thrombocytopenia * 1  7/217 (3.23%)  0/215 (0.00%) 
Pancytopenia * 2  1/217 (0.46%)  0/215 (0.00%) 
Cardiac disorders     
Cardiac failure acute * 1  1/217 (0.46%)  0/215 (0.00%) 
Congestive cardiomyopathy * 1  0/217 (0.00%)  1/215 (0.47%) 
Pericardial effusion * 1  1/217 (0.46%)  0/215 (0.00%) 
Supraventricular tachycardia * 1  0/217 (0.00%)  1/215 (0.47%) 
Ventricular extrasystoles * 1  1/217 (0.46%)  0/215 (0.00%) 
Ear and labyrinth disorders     
Vertigo * 1  1/217 (0.46%)  0/215 (0.00%) 
Endocrine disorders     
Hypothyroidism * 1  2/217 (0.92%)  0/215 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  2/217 (0.92%)  2/215 (0.93%) 
Abdominal pain upper * 1  1/217 (0.46%)  0/215 (0.00%) 
Anal fissure * 1  1/217 (0.46%)  0/215 (0.00%) 
Ascites * 1  1/217 (0.46%)  2/215 (0.93%) 
Colitis * 1  0/217 (0.00%)  1/215 (0.47%) 
Colonic obstruction * 1  0/217 (0.00%)  1/215 (0.47%) 
Constipation * 1  0/217 (0.00%)  2/215 (0.93%) 
Diarrhoea * 1  9/217 (4.15%)  13/215 (6.05%) 
Diverticular perforation * 1  1/217 (0.46%)  0/215 (0.00%) 
Duodenal stenosis * 1  0/217 (0.00%)  1/215 (0.47%) 
Dyspepsia * 1  1/217 (0.46%)  0/215 (0.00%) 
Dysphagia * 1  1/217 (0.46%)  1/215 (0.47%) 
Enteritis * 1  1/217 (0.46%)  0/215 (0.00%) 
Gastritis * 1  2/217 (0.92%)  1/215 (0.47%) 
Gastrointestinal haemorrhage * 1  1/217 (0.46%)  0/215 (0.00%) 
Intestinal obstruction * 1  0/217 (0.00%)  1/215 (0.47%) 
Nausea * 1  6/217 (2.76%)  1/215 (0.47%) 
Pancreatitis haemorrhagic * 1  1/217 (0.46%)  0/215 (0.00%) 
Peritonitis * 1  1/217 (0.46%)  0/215 (0.00%) 
Small intestinal obstruction * 1  1/217 (0.46%)  1/215 (0.47%) 
Stomatitis * 1  0/217 (0.00%)  1/215 (0.47%) 
Subileus * 1  2/217 (0.92%)  1/215 (0.47%) 
Upper gastrointestinal haemorrhage * 1  1/217 (0.46%)  0/215 (0.00%) 
Vomiting * 1  11/217 (5.07%)  6/215 (2.79%) 
General disorders     
Asthenia * 1  6/217 (2.76%)  0/215 (0.00%) 
Chest pain * 1  1/217 (0.46%)  2/215 (0.93%) 
Chills * 1  0/217 (0.00%)  1/215 (0.47%) 
Death * 1  1/217 (0.46%)  0/215 (0.00%) 
Disease progression * 1  10/217 (4.61%)  7/215 (3.26%) 
Fatigue * 1  2/217 (0.92%)  2/215 (0.93%) 
General physical health deterioration * 1  3/217 (1.38%)  1/215 (0.47%) 
Malaise * 1  1/217 (0.46%)  0/215 (0.00%) 
Mucosal inflammation * 1  2/217 (0.92%)  1/215 (0.47%) 
Pain * 1  0/217 (0.00%)  1/215 (0.47%) 
Pyrexia * 1  2/217 (0.92%)  6/215 (2.79%) 
Ulcer * 2  0/217 (0.00%)  1/215 (0.47%) 
HAEMATEMESIS SECONDARY TO THROMBCYTOPENIA * 2  1/217 (0.46%)  0/215 (0.00%) 
Hepatobiliary disorders     
Cytolytic hepatitis * 1  1/217 (0.46%)  0/215 (0.00%) 
Hepatic failure * 1  1/217 (0.46%)  0/215 (0.00%) 
Hepatic haemorrhage * 1  1/217 (0.46%)  0/215 (0.00%) 
Hyperbilirubinaemia * 1  1/217 (0.46%)  1/215 (0.47%) 
Jaundice * 1  1/217 (0.46%)  0/215 (0.00%) 
Infections and infestations     
Breast infection * 1  1/217 (0.46%)  0/215 (0.00%) 
Erysipelas * 1  1/217 (0.46%)  0/215 (0.00%) 
Gastroenteritis * 1  0/217 (0.00%)  1/215 (0.47%) 
Infection * 1  1/217 (0.46%)  0/215 (0.00%) 
Neutropenic sepsis * 1  1/217 (0.46%)  1/215 (0.47%) 
Pneumonia * 1  2/217 (0.92%)  1/215 (0.47%) 
Pyelonephritis * 1  0/217 (0.00%)  1/215 (0.47%) 
Sepsis * 1  0/217 (0.00%)  3/215 (1.40%) 
Tooth infection * 1  1/217 (0.46%)  0/215 (0.00%) 
Urinary tract infection * 1  0/217 (0.00%)  1/215 (0.47%) 
Cellulitis * 2  1/217 (0.46%)  0/215 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 1  0/217 (0.00%)  1/215 (0.47%) 
Hip fracture * 1  0/217 (0.00%)  1/215 (0.47%) 
Radiation skin injury * 1  1/217 (0.46%)  0/215 (0.00%) 
Radius fracture * 1  0/217 (0.00%)  1/215 (0.47%) 
Subdural haematoma * 1  1/217 (0.46%)  0/215 (0.00%) 
Wrist fracture * 1  0/217 (0.00%)  1/215 (0.47%) 
Investigations     
Ejection fraction decreased * 1  1/217 (0.46%)  0/215 (0.00%) 
Electrocardiogram ST segment depression * 1  1/217 (0.46%)  0/215 (0.00%) 
Haemoglobin decreased * 1  0/217 (0.00%)  2/215 (0.93%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/217 (0.46%)  0/215 (0.00%) 
Dehydration * 1  1/217 (0.46%)  1/215 (0.47%) 
Diabetes mellitus * 1  1/217 (0.46%)  0/215 (0.00%) 
Hypercalcaemia * 1  1/217 (0.46%)  0/215 (0.00%) 
Hypokalaemia * 1  1/217 (0.46%)  1/215 (0.47%) 
Hyponatraemia * 1  1/217 (0.46%)  0/215 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/217 (0.46%)  0/215 (0.00%) 
Bone pain * 1  1/217 (0.46%)  0/215 (0.00%) 
Muscular weakness * 1  1/217 (0.46%)  0/215 (0.00%) 
Musculoskeletal chest pain * 1  1/217 (0.46%)  0/215 (0.00%) 
Myalgia * 1  1/217 (0.46%)  0/215 (0.00%) 
Osteolysis * 1  0/217 (0.00%)  1/215 (0.47%) 
Pain in extremity * 1  0/217 (0.00%)  1/215 (0.47%) 
Pathological fracture * 1  0/217 (0.00%)  2/215 (0.93%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  2/217 (0.92%)  1/215 (0.47%) 
Lung neoplasm * 1  0/217 (0.00%)  1/215 (0.47%) 
Malignant pleural effusion * 1  0/217 (0.00%)  1/215 (0.47%) 
Nervous system disorders     
Cerebral haemorrhage * 1  1/217 (0.46%)  0/215 (0.00%) 
Cerebrovascular accident * 1  1/217 (0.46%)  1/215 (0.47%) 
Convulsion * 1  1/217 (0.46%)  0/215 (0.00%) 
Diabetic coma * 1  0/217 (0.00%)  1/215 (0.47%) 
Facial paresis * 1  1/217 (0.46%)  0/215 (0.00%) 
Hypoaesthesia * 1  0/217 (0.00%)  1/215 (0.47%) 
Neuralgia * 1  0/217 (0.00%)  1/215 (0.47%) 
Paraplegia * 1  1/217 (0.46%)  0/215 (0.00%) 
Psychiatric disorders     
Psychotic disorder * 2  0/217 (0.00%)  1/215 (0.47%) 
Renal and urinary disorders     
Nephrolithiasis * 1  0/217 (0.00%)  1/215 (0.47%) 
Renal failure * 1  1/217 (0.46%)  1/215 (0.47%) 
Renal infarct * 1  1/217 (0.46%)  0/215 (0.00%) 
Renal pain * 1  1/217 (0.46%)  0/215 (0.00%) 
Reproductive system and breast disorders     
Metrorrhagia * 1  1/217 (0.46%)  1/215 (0.47%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/217 (0.00%)  1/215 (0.47%) 
Dyspnoea * 1  4/217 (1.84%)  3/215 (1.40%) 
Haemoptysis * 1  1/217 (0.46%)  2/215 (0.93%) 
Hydrothorax * 1  2/217 (0.92%)  0/215 (0.00%) 
Pleural effusion * 1  1/217 (0.46%)  3/215 (1.40%) 
Pneumonitis * 1  0/217 (0.00%)  1/215 (0.47%) 
Pneumothorax * 1  1/217 (0.46%)  1/215 (0.47%) 
Pulmonary embolism * 1  8/217 (3.69%)  2/215 (0.93%) 
Skin and subcutaneous tissue disorders     
Palmar—plantar erythrodysaesthesia syndrome * 1  0/217 (0.00%)  3/215 (1.40%) 
Surgical and medical procedures     
Ureteral catheterisation * 1  1/217 (0.46%)  0/215 (0.00%) 
Vascular disorders     
Hypertension * 1  2/217 (0.92%)  0/215 (0.00%) 
Iliac artery thrombosis * 1  1/217 (0.46%)  0/215 (0.00%) 
Thrombosis * 1  1/217 (0.46%)  1/215 (0.47%) 
Venous thrombosis * 1  0/217 (0.00%)  1/215 (0.47%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MedDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sunitinib + Capecitabine Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   214/217 (98.62%)   208/215 (96.74%) 
Blood and lymphatic system disorders     
Anaemia * 1  53/217 (24.42%)  35/215 (16.28%) 
Leukopenia * 1  51/217 (23.50%)  19/215 (8.84%) 
Neutropenia * 1  104/217 (47.93%)  39/215 (18.14%) 
Thrombocytopenia * 1  102/217 (47.00%)  14/215 (6.51%) 
Febrile neutropenia * 2  2/217 (0.92%)  0/215 (0.00%) 
Haematotoxicity * 2  2/217 (0.92%)  0/215 (0.00%) 
Haemorrhagic diathesis * 2  1/217 (0.46%)  0/215 (0.00%) 
Leukocytosis * 2  1/217 (0.46%)  0/215 (0.00%) 
Lymphadenopathy * 2  1/217 (0.46%)  0/215 (0.00%) 
Lymphocytosis * 2  1/217 (0.46%)  0/215 (0.00%) 
Lymphopenia * 2  5/217 (2.30%)  0/215 (0.00%) 
Macrocytosis * 2  0/217 (0.00%)  1/215 (0.47%) 
Pancytopenia * 2  1/217 (0.46%)  0/215 (0.00%) 
Cardiac disorders     
Angina pectoris * 2  3/217 (1.38%)  0/215 (0.00%) 
Arrhythmia * 2  2/217 (0.92%)  0/215 (0.00%) 
Atrial fibrillation * 2  0/217 (0.00%)  2/215 (0.93%) 
Bradycardia * 2  2/217 (0.92%)  0/215 (0.00%) 
Cardiac disorder * 2  1/217 (0.46%)  0/215 (0.00%) 
Cardiovascular disorder * 2  1/217 (0.46%)  0/215 (0.00%) 
Cyanosis * 2  1/217 (0.46%)  0/215 (0.00%) 
Left ventricular dysfunction * 2  4/217 (1.84%)  1/215 (0.47%) 
Palpitations * 2  4/217 (1.84%)  1/215 (0.47%) 
Pericardial effusion * 2  3/217 (1.38%)  1/215 (0.47%) 
Pericarditis * 2  0/217 (0.00%)  1/215 (0.47%) 
Sinus bradycardia * 2  1/217 (0.46%)  0/215 (0.00%) 
Sinus tachycardia * 2  1/217 (0.46%)  4/215 (1.86%) 
Tachycardia * 2  2/217 (0.92%)  2/215 (0.93%) 
Ear and labyrinth disorders     
Ear pain * 2  4/217 (1.84%)  0/215 (0.00%) 
Tinnitus * 2  3/217 (1.38%)  3/215 (1.40%) 
Vertigo * 2  8/217 (3.69%)  13/215 (6.05%) 
Endocrine disorders     
Hypothyroidism * 1  22/217 (10.14%)  2/215 (0.93%) 
Hyperthyroidism * 2  1/217 (0.46%)  0/215 (0.00%) 
Eye disorders     
Conjunctivitis * 1  4/217 (1.84%)  16/215 (7.44%) 
Lacrimation increased * 1  23/217 (10.60%)  24/215 (11.16%) 
Conjunctival haemorrhage * 2  1/217 (0.46%)  0/215 (0.00%) 
Conjunctival irritation * 2  0/217 (0.00%)  1/215 (0.47%) 
Diplopia * 2  2/217 (0.92%)  0/215 (0.00%) 
Dry eye * 2  7/217 (3.23%)  4/215 (1.86%) 
Exophthalmos * 2  1/217 (0.46%)  0/215 (0.00%) 
Eye disorder * 2  1/217 (0.46%)  0/215 (0.00%) 
Eye inflammation * 2  1/217 (0.46%)  0/215 (0.00%) 
Eye irritation * 2  5/217 (2.30%)  7/215 (3.26%) 
Eye oedema * 2  2/217 (0.92%)  2/215 (0.93%) 
Eye pain * 2  2/217 (0.92%)  1/215 (0.47%) 
Eye swelling * 2  1/217 (0.46%)  0/215 (0.00%) 
Eyelash discolouration * 2  2/217 (0.92%)  0/215 (0.00%) 
Eyelid oedema * 2  5/217 (2.30%)  0/215 (0.00%) 
Eyelid ptosis * 2  1/217 (0.46%)  1/215 (0.47%) 
Keratitis * 2  1/217 (0.46%)  0/215 (0.00%) 
Mydriasis * 2  0/217 (0.00%)  1/215 (0.47%) 
Ocular discomfort * 2  0/217 (0.00%)  1/215 (0.47%) 
Ocular hyperaemia * 2  0/217 (0.00%)  1/215 (0.47%) 
Ocular icterus * 2  1/217 (0.46%)  0/215 (0.00%) 
Periorbital oedema * 2  2/217 (0.92%)  0/215 (0.00%) 
Photophobia * 2  0/217 (0.00%)  1/215 (0.47%) 
Retinal disorder * 2  0/217 (0.00%)  1/215 (0.47%) 
Vision blurred * 2  1/217 (0.46%)  2/215 (0.93%) 
Visual acuity reduced * 2  1/217 (0.46%)  0/215 (0.00%) 
Visual impairment * 2  9/217 (4.15%)  1/215 (0.47%) 
Vitreous floaters * 2  2/217 (0.92%)  0/215 (0.00%) 
Xerophthalmia * 2  1/217 (0.46%)  0/215 (0.00%) 
Abdominal distension * 2  2/217 (0.92%)  4/215 (1.86%) 
Gastrointestinal disorders     
Abdominal pain * 1  38/217 (17.51%)  29/215 (13.49%) 
Abdominal pain upper * 1  48/217 (22.12%)  30/215 (13.95%) 
Constipation * 1  41/217 (18.89%)  42/215 (19.53%) 
Diarrhoea * 1  121/217 (55.76%)  95/215 (44.19%) 
Dry mouth * 1  19/217 (8.76%)  16/215 (7.44%) 
Dyspepsia * 1  38/217 (17.51%)  13/215 (6.05%) 
Dysphagia * 1  13/217 (5.99%)  1/215 (0.47%) 
Flatulence * 1  13/217 (5.99%)  11/215 (5.12%) 
Gastrooesophageal reflux disease * 1  12/217 (5.53%)  5/215 (2.33%) 
Gingivitis * 1  11/217 (5.07%)  2/215 (0.93%) 
Nausea * 1  122/217 (56.22%)  91/215 (42.33%) 
Oesophagitis * 1  14/217 (6.45%)  2/215 (0.93%) 
Stomatitis * 1  61/217 (28.11%)  26/215 (12.09%) 
Vomiting * 1  90/217 (41.47%)  55/215 (25.58%) 
Abdominal discomfort * 2  1/217 (0.46%)  1/215 (0.47%) 
Abdominal hernia * 2  1/217 (0.46%)  0/215 (0.00%) 
Abdominal pain lower * 2  0/217 (0.00%)  1/215 (0.47%) 
Abdominal rigidity * 2  1/217 (0.46%)  2/215 (0.93%) 
Anal inflammation * 2  4/217 (1.84%)  0/215 (0.00%) 
Anal stenosis * 2  0/217 (0.00%)  1/215 (0.47%) 
Anorectal discomfort * 2  0/217 (0.00%)  1/215 (0.47%) 
Aphthous stomatitis * 2  8/217 (3.69%)  5/215 (2.33%) 
Ascites * 2  5/217 (2.30%)  2/215 (0.93%) 
Chapped lips * 2  0/217 (0.00%)  1/215 (0.47%) 
Cheilitis * 2  1/217 (0.46%)  3/215 (1.40%) 
Colitis * 2  2/217 (0.92%)  0/215 (0.00%) 
Dental caries * 2  1/217 (0.46%)  0/215 (0.00%) 
Epigastric discomfort * 2  0/217 (0.00%)  1/215 (0.47%) 
Eructation * 2  4/217 (1.84%)  0/215 (0.00%) 
Faecal incontinence * 2  1/217 (0.46%)  0/215 (0.00%) 
Food poisoning * 2  1/217 (0.46%)  0/215 (0.00%) 
Gastric disorder * 2  1/217 (0.46%)  0/215 (0.00%) 
Gastritis * 2  1/217 (0.46%)  1/215 (0.47%) 
Gastrointestinal disorder * 2  1/217 (0.46%)  1/215 (0.47%) 
Gastrointestinal hypermotility * 2  1/217 (0.46%)  0/215 (0.00%) 
Gastrointestinal pain * 2  0/217 (0.00%)  1/215 (0.47%) 
Gingival bleeding * 2  9/217 (4.15%)  1/215 (0.47%) 
Gingival disorder * 2  1/217 (0.46%)  0/215 (0.00%) 
Gingival oedema * 2  1/217 (0.46%)  0/215 (0.00%) 
Gingival pain * 2  4/217 (1.84%)  1/215 (0.47%) 
Gingival swelling * 2  1/217 (0.46%)  0/215 (0.00%) 
Gingival ulceration * 2  1/217 (0.46%)  0/215 (0.00%) 
Glossitis * 2  2/217 (0.92%)  0/215 (0.00%) 
Glossodynia * 2  6/217 (2.76%)  0/215 (0.00%) 
Haematemesis * 2  1/217 (0.46%)  0/215 (0.00%) 
Haematochezia * 2  2/217 (0.92%)  0/215 (0.00%) 
Haemorrhoids * 2  5/217 (2.30%)  7/215 (3.26%) 
Hypoaesthesia oral * 2  0/217 (0.00%)  1/215 (0.47%) 
Ileitis * 2  0/217 (0.00%)  1/215 (0.47%) 
Irritable bowel syndrome * 2  0/217 (0.00%)  1/215 (0.47%) 
Lip dry * 2  0/217 (0.00%)  3/215 (1.40%) 
Lip haematoma * 2  0/217 (0.00%)  1/215 (0.47%) 
Lip pain * 2  1/217 (0.46%)  0/215 (0.00%) 
Loose tooth * 2  1/217 (0.46%)  0/215 (0.00%) 
Mouth haemorrhage * 2  1/217 (0.46%)  0/215 (0.00%) 
Mouth ulceration * 2  4/217 (1.84%)  1/215 (0.47%) 
Odynophagia * 2  2/217 (0.92%)  0/215 (0.00%) 
Oedema mouth * 2  1/217 (0.46%)  0/215 (0.00%) 
Oesophageal disorder * 2  1/217 (0.46%)  1/215 (0.47%) 
Oesophageal pain * 2  1/217 (0.46%)  2/215 (0.93%) 
Oral discomfort * 2  3/217 (1.38%)  0/215 (0.00%) 
Oral mucosal eruption * 2  1/217 (0.46%)  0/215 (0.00%) 
Oral mucosal erythema * 2  0/217 (0.00%)  1/215 (0.47%) 
Oral pain * 2  8/217 (3.69%)  0/215 (0.00%) 
Pancreatitis * 2  1/217 (0.46%)  0/215 (0.00%) 
Paraesthesia oral * 2  1/217 (0.46%)  1/215 (0.47%) 
Periodontal disease * 2  1/217 (0.46%)  0/215 (0.00%) 
Proctalgia * 2  2/217 (0.92%)  0/215 (0.00%) 
Proctitis * 2  0/217 (0.00%)  1/215 (0.47%) 
Rectal haemorrhage * 2  7/217 (3.23%)  2/215 (0.93%) 
Reflux oesophagitis * 2  2/217 (0.92%)  0/215 (0.00%) 
Sensitivity of teeth * 2  2/217 (0.92%)  2/215 (0.93%) 
Tongue discolouration * 2  1/217 (0.46%)  1/215 (0.47%) 
Tongue oedema * 2  1/217 (0.46%)  0/215 (0.00%) 
Tongue ulceration * 2  1/217 (0.46%)  0/215 (0.00%) 
Tooth disorder * 2  0/217 (0.00%)  2/215 (0.93%) 
Toothache * 2  5/217 (2.30%)  2/215 (0.93%) 
Umbilical hernia * 2  1/217 (0.46%)  0/215 (0.00%) 
General disorders     
Asthenia * 1  75/217 (34.56%)  49/215 (22.79%) 
Chest pain * 1  12/217 (5.53%)  12/215 (5.58%) 
Fatigue * 1  65/217 (29.95%)  53/215 (24.65%) 
Mucosal inflammation * 1  49/217 (22.58%)  24/215 (11.16%) 
Oedema peripheral * 1  16/217 (7.37%)  19/215 (8.84%) 
Pain * 1  11/217 (5.07%)  8/215 (3.72%) 
Pyrexia * 1  21/217 (9.68%)  15/215 (6.98%) 
Axillary pain * 2  8/217 (3.69%)  3/215 (1.40%) 
Catheter site pain * 2  0/217 (0.00%)  1/215 (0.47%) 
Catheter site rash * 2  1/217 (0.46%)  0/215 (0.00%) 
Chest discomfort * 2  2/217 (0.92%)  1/215 (0.47%) 
Chills * 2  5/217 (2.30%)  3/215 (1.40%) 
Condition aggravated * 2  1/217 (0.46%)  2/215 (0.93%) 
Disease progression * 2  1/217 (0.46%)  0/215 (0.00%) 
Face oedema * 2  6/217 (2.76%)  2/215 (0.93%) 
Feeling abnormal * 2  1/217 (0.46%)  0/215 (0.00%) 
Feeling cold * 2  2/217 (0.92%)  1/215 (0.47%) 
Feeling hot * 2  1/217 (0.46%)  0/215 (0.00%) 
Gait disturbance * 2  2/217 (0.92%)  0/215 (0.00%) 
General physical health deterioration * 2  3/217 (1.38%)  3/215 (1.40%) 
Hyperthermia * 2  3/217 (1.38%)  0/215 (0.00%) 
Induration * 2  1/217 (0.46%)  0/215 (0.00%) 
Inflammation * 2  0/217 (0.00%)  1/215 (0.47%) 
Influenza like illness * 2  3/217 (1.38%)  6/215 (2.79%) 
Infusion site extravasation * 2  0/217 (0.00%)  1/215 (0.47%) 
Injection site thrombosis * 2  0/217 (0.00%)  1/215 (0.47%) 
Local swelling * 2  0/217 (0.00%)  1/215 (0.47%) 
Localised oedema * 2  1/217 (0.46%)  0/215 (0.00%) 
Malaise * 2  1/217 (0.46%)  1/215 (0.47%) 
Mass * 2  0/217 (0.00%)  1/215 (0.47%) 
Nodule * 2  1/217 (0.46%)  1/215 (0.47%) 
Oedema * 2  4/217 (1.84%)  2/215 (0.93%) 
Secretion discharge * 2  1/217 (0.46%)  0/215 (0.00%) 
Swelling * 2  0/217 (0.00%)  1/215 (0.47%) 
Temperature intolerance * 2  1/217 (0.46%)  0/215 (0.00%) 
Thirst * 2  0/217 (0.00%)  1/215 (0.47%) 
Ulcer * 2  1/217 (0.46%)  2/215 (0.93%) 
Xerosis * 2  3/217 (1.38%)  3/215 (1.40%) 
Hepatobiliary disorders     
Hyperbilirubinaemia * 1  13/217 (5.99%)  13/215 (6.05%) 
Jaundice * 1  11/217 (5.07%)  0/215 (0.00%) 
Cholelithiasis * 2  2/217 (0.92%)  0/215 (0.00%) 
Hepatic failure * 2  1/217 (0.46%)  0/215 (0.00%) 
Hepatic function abnormal * 2  1/217 (0.46%)  0/215 (0.00%) 
Hepatic pain * 2  2/217 (0.92%)  1/215 (0.47%) 
Hepatomegaly * 2  1/217 (0.46%)  1/215 (0.47%) 
Hepatotoxicity * 2  0/217 (0.00%)  1/215 (0.47%) 
Hypertransaminasaemia * 2  2/217 (0.92%)  0/215 (0.00%) 
Portal vein thrombosis * 2  0/217 (0.00%)  1/215 (0.47%) 
Immune system disorders     
Drug hypersensitivity * 2  0/217 (0.00%)  1/215 (0.47%) 
Hypersensitivity * 2  0/217 (0.00%)  1/215 (0.47%) 
Seasonal allergy * 2  1/217 (0.46%)  2/215 (0.93%) 
Infections and infestations     
Nasopharyngitis * 1  16/217 (7.37%)  10/215 (4.65%) 
Rhinitis * 1  1/217 (0.46%)  13/215 (6.05%) 
Urinary tract infection * 1  16/217 (7.37%)  11/215 (5.12%) 
Abscess * 2  1/217 (0.46%)  0/215 (0.00%) 
Bronchitis * 2  7/217 (3.23%)  7/215 (3.26%) 
Bronchopneumonia * 2  1/217 (0.46%)  0/215 (0.00%) 
Candidiasis * 2  1/217 (0.46%)  1/215 (0.47%) 
Cellulitis * 2  1/217 (0.46%)  3/215 (1.40%) 
Clostridial infection * 2  1/217 (0.46%)  0/215 (0.00%) 
Conjunctivitis infective * 2  1/217 (0.46%)  1/215 (0.47%) 
Cystitis * 2  5/217 (2.30%)  6/215 (2.79%) 
Device related infection * 2  2/217 (0.92%)  0/215 (0.00%) 
Ear infection * 2  1/217 (0.46%)  1/215 (0.47%) 
Erysipelas * 2  0/217 (0.00%)  1/215 (0.47%) 
Escherichia infection * 2  1/217 (0.46%)  0/215 (0.00%) 
Escherichia urinary tract infection * 2  1/217 (0.46%)  0/215 (0.00%) 
Eye infection * 2  0/217 (0.00%)  2/215 (0.93%) 
Folliculitis * 2  0/217 (0.00%)  1/215 (0.47%) 
Gastroenteritis * 2  1/217 (0.46%)  2/215 (0.93%) 
Gastroenteritis viral * 2  0/217 (0.00%)  5/215 (2.33%) 
Herpes simplex * 2  4/217 (1.84%)  3/215 (1.40%) 
Herpes virus infection * 2  1/217 (0.46%)  1/215 (0.47%) 
Herpes zoster * 2  0/217 (0.00%)  2/215 (0.93%) 
Infected skin ulcer * 2  0/217 (0.00%)  1/215 (0.47%) 
Infection * 2  2/217 (0.92%)  2/215 (0.93%) 
Influenza * 2  7/217 (3.23%)  7/215 (3.26%) 
Laryngitis * 2  3/217 (1.38%)  3/215 (1.40%) 
Localised infection * 2  1/217 (0.46%)  3/215 (1.40%) 
Lower respiratory tract infection * 2  0/217 (0.00%)  4/215 (1.86%) 
Lung infection * 2  1/217 (0.46%)  0/215 (0.00%) 
Lymphangitis * 2  0/217 (0.00%)  1/215 (0.47%) 
Nail bed infection * 2  1/217 (0.46%)  2/215 (0.93%) 
Nail infection * 2  0/217 (0.00%)  1/215 (0.47%) 
Oesophageal candidiasis * 2  2/217 (0.92%)  0/215 (0.00%) 
Onychomycosis * 2  0/217 (0.00%)  2/215 (0.93%) 
Oral candidiasis * 2  1/217 (0.46%)  3/215 (1.40%) 
Oral fungal infection * 2  1/217 (0.46%)  0/215 (0.00%) 
Oral herpes * 2  0/217 (0.00%)  3/215 (1.40%) 
Oral infection * 2  0/217 (0.00%)  1/215 (0.47%) 
Osteomyelitis * 2  1/217 (0.46%)  1/215 (0.47%) 
Otitis media * 2  1/217 (0.46%)  0/215 (0.00%) 
Paronychia * 2  0/217 (0.00%)  2/215 (0.93%) 
Pharyngitis * 2  4/217 (1.84%)  5/215 (2.33%) 
Puncture site infection * 2  0/217 (0.00%)  1/215 (0.47%) 
Rectal abscess * 2  1/217 (0.46%)  0/215 (0.00%) 
Respiratory tract infection * 2  1/217 (0.46%)  1/215 (0.47%) 
Sinusitis * 2  0/217 (0.00%)  3/215 (1.40%) 
Skin infection * 2  2/217 (0.92%)  0/215 (0.00%) 
Subcutaneous abscess * 2  1/217 (0.46%)  0/215 (0.00%) 
Tinea pedis * 2  0/217 (0.00%)  3/215 (1.40%) 
Tooth abscess * 2  9/217 (4.15%)  4/215 (1.86%) 
Tooth infection * 2  4/217 (1.84%)  0/215 (0.00%) 
Tracheitis * 2  0/217 (0.00%)  1/215 (0.47%) 
Upper respiratory tract infection * 2  1/217 (0.46%)  3/215 (1.40%) 
Vaginal infection * 2  2/217 (0.92%)  0/215 (0.00%) 
Viral infection * 2  1/217 (0.46%)  3/215 (1.40%) 
Viral upper respiratory tract infection * 2  0/217 (0.00%)  1/215 (0.47%) 
Vulvovaginal candidiasis * 2  3/217 (1.38%)  1/215 (0.47%) 
Vulvovaginal mycotic infection * 2  2/217 (0.92%)  1/215 (0.47%) 
Vulvovaginitis * 2  0/217 (0.00%)  1/215 (0.47%) 
Wound infection * 2  1/217 (0.46%)  0/215 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose * 2  3/217 (1.38%)  0/215 (0.00%) 
Animal bite * 2  0/217 (0.00%)  1/215 (0.47%) 
Arthropod bite * 2  1/217 (0.46%)  1/215 (0.47%) 
Clavicle fracture * 2  1/217 (0.46%)  0/215 (0.00%) 
Contusion * 2  1/217 (0.46%)  1/215 (0.47%) 
Fall * 2  1/217 (0.46%)  2/215 (0.93%) 
Foreign body * 2  0/217 (0.00%)  1/215 (0.47%) 
Hand fracture * 2  0/217 (0.00%)  1/215 (0.47%) 
Injury * 2  0/217 (0.00%)  1/215 (0.47%) 
Joint injury * 2  0/217 (0.00%)  1/215 (0.47%) 
Joint sprain * 2  0/217 (0.00%)  2/215 (0.93%) 
Ligament injury * 2  0/217 (0.00%)  1/215 (0.47%) 
Lip injury * 2  1/217 (0.46%)  0/215 (0.00%) 
Open wound * 2  1/217 (0.46%)  0/215 (0.00%) 
Overdose * 2  2/217 (0.92%)  0/215 (0.00%) 
Pelvic fracture * 2  1/217 (0.46%)  0/215 (0.00%) 
Radius fracture * 2  0/217 (0.00%)  1/215 (0.47%) 
Rib fracture * 2  0/217 (0.00%)  2/215 (0.93%) 
Seroma * 2  1/217 (0.46%)  0/215 (0.00%) 
Tooth fracture * 2  0/217 (0.00%)  1/215 (0.47%) 
Whiplash injury * 2  0/217 (0.00%)  1/215 (0.47%) 
Wound * 2  2/217 (0.92%)  2/215 (0.93%) 
Wrist fracture * 2  0/217 (0.00%)  1/215 (0.47%) 
Investigations     
Alanine aminotransferase increased * 1  11/217 (5.07%)  15/215 (6.98%) 
Aspartate aminotransferase increased * 1  19/217 (8.76%)  13/215 (6.05%) 
Blood alkaline phosphatase increased * 1  12/217 (5.53%)  8/215 (3.72%) 
Platelet count decreased * 1  15/217 (6.91%)  4/215 (1.86%) 
Weight decreased * 1  20/217 (9.22%)  17/215 (7.91%) 
Blood albumin decreased * 2  1/217 (0.46%)  0/215 (0.00%) 
Blood bilirubin increased * 2  6/217 (2.76%)  3/215 (1.40%) 
Blood creatinine increased * 2  1/217 (0.46%)  0/215 (0.00%) 
Blood glucose increased * 2  0/217 (0.00%)  1/215 (0.47%) 
Blood iron increased * 2  1/217 (0.46%)  0/215 (0.00%) 
Blood lactate dehydrogenase increased * 2  2/217 (0.92%)  0/215 (0.00%) 
Blood phosphorus decreased * 2  0/217 (0.00%)  1/215 (0.47%) 
Blood potassium decreased * 2  2/217 (0.92%)  2/215 (0.93%) 
Blood pressure decreased * 2  0/217 (0.00%)  1/215 (0.47%) 
Blood pressure increased * 2  1/217 (0.46%)  0/215 (0.00%) 
Blood thyroid stimulating hormone increased * 2  7/217 (3.23%)  4/215 (1.86%) 
Blood uric acid increased * 2  2/217 (0.92%)  1/215 (0.47%) 
Breath sounds abnormal * 2  0/217 (0.00%)  2/215 (0.93%) 
Creatinine renal clearance decreased * 2  0/217 (0.00%)  1/215 (0.47%) 
Ejection fraction decreased * 2  8/217 (3.69%)  3/215 (1.40%) 
Electrocardiogram QT prolonged * 2  2/217 (0.92%)  0/215 (0.00%) 
Electrocardiogram T wave abnormal * 2  1/217 (0.46%)  0/215 (0.00%) 
Gamma-glutamyltransferase increased * 2  3/217 (1.38%)  1/215 (0.47%) 
Haemoglobin * 2  1/217 (0.46%)  0/215 (0.00%) 
Haemoglobin decreased * 2  2/217 (0.92%)  2/215 (0.93%) 
Heart rate increased * 2  0/217 (0.00%)  1/215 (0.47%) 
Hepatic enzyme increased * 2  1/217 (0.46%)  0/215 (0.00%) 
Liver function test abnormal * 2  1/217 (0.46%)  0/215 (0.00%) 
Neutrophil count decreased * 2  5/217 (2.30%)  1/215 (0.47%) 
Protein total increased * 2  0/217 (0.00%)  1/215 (0.47%) 
Respiratory rate increased * 2  0/217 (0.00%)  1/215 (0.47%) 
Thyroid function test abnormal * 2  1/217 (0.46%)  0/215 (0.00%) 
Transaminases increased * 2  2/217 (0.92%)  1/215 (0.47%) 
Weight increased * 2  2/217 (0.92%)  5/215 (2.33%) 
White blood cell count decreased * 2  7/217 (3.23%)  2/215 (0.93%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  67/217 (30.88%)  44/215 (20.47%) 
Hypokalaemia * 1  11/217 (5.07%)  8/215 (3.72%) 
Cachexia * 2  1/217 (0.46%)  0/215 (0.00%) 
Dehydration * 2  4/217 (1.84%)  8/215 (3.72%) 
Diabetes mellitus * 2  1/217 (0.46%)  0/215 (0.00%) 
Hypercalcaemia * 2  5/217 (2.30%)  0/215 (0.00%) 
Hypercholesterolaemia * 2  2/217 (0.92%)  3/215 (1.40%) 
Hyperglycaemia * 2  6/217 (2.76%)  9/215 (4.19%) 
Hyperkalaemia * 2  0/217 (0.00%)  1/215 (0.47%) 
Hypermagnesaemia * 2  1/217 (0.46%)  0/215 (0.00%) 
Hyperphosphataemia * 2  1/217 (0.46%)  0/215 (0.00%) 
Hypertriglyceridaemia * 2  4/217 (1.84%)  3/215 (1.40%) 
Hyperuricaemia * 2  4/217 (1.84%)  2/215 (0.93%) 
Hypoalbuminaemia * 2  1/217 (0.46%)  4/215 (1.86%) 
Hypocalcaemia * 2  5/217 (2.30%)  5/215 (2.33%) 
Hypomagnesaemia * 2  2/217 (0.92%)  4/215 (1.86%) 
Hyponatraemia * 2  1/217 (0.46%)  2/215 (0.93%) 
Hypoproteinaemia * 2  0/217 (0.00%)  2/215 (0.93%) 
Hypovolaemia * 2  0/217 (0.00%)  1/215 (0.47%) 
Polydipsia * 2  0/217 (0.00%)  1/215 (0.47%) 
Tetany * 2  1/217 (0.46%)  0/215 (0.00%) 
Vitamin K deficiency * 2  1/217 (0.46%)  0/215 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  24/217 (11.06%)  25/215 (11.63%) 
Back pain * 1  25/217 (11.52%)  23/215 (10.70%) 
Bone pain * 1  13/217 (5.99%)  12/215 (5.58%) 
Musculoskeletal pain * 1  13/217 (5.99%)  13/215 (6.05%) 
Myalgia * 1  19/217 (8.76%)  7/215 (3.26%) 
Pain in extremity * 1  25/217 (11.52%)  33/215 (15.35%) 
Bone disorder * 2  0/217 (0.00%)  1/215 (0.47%) 
Bone swelling * 2  0/217 (0.00%)  1/215 (0.47%) 
Coccydynia * 2  0/217 (0.00%)  1/215 (0.47%) 
Costochondritis * 2  0/217 (0.00%)  1/215 (0.47%) 
Fistula * 2  1/217 (0.46%)  0/215 (0.00%) 
Flank pain * 2  2/217 (0.92%)  1/215 (0.47%) 
Groin pain * 2  1/217 (0.46%)  0/215 (0.00%) 
Hypercreatinaemia * 2  4/217 (1.84%)  3/215 (1.40%) 
Joint lock * 2  1/217 (0.46%)  0/215 (0.00%) 
Joint range of motion decreased * 2  0/217 (0.00%)  1/215 (0.47%) 
Joint stiffness * 2  1/217 (0.46%)  0/215 (0.00%) 
Joint swelling * 2  0/217 (0.00%)  1/215 (0.47%) 
Mobility decreased * 2  0/217 (0.00%)  2/215 (0.93%) 
Muscle spasms * 2  3/217 (1.38%)  10/215 (4.65%) 
Muscular weakness * 2  5/217 (2.30%)  3/215 (1.40%) 
Musculoskeletal chest pain * 2  8/217 (3.69%)  7/215 (3.26%) 
Musculoskeletal stiffness * 2  3/217 (1.38%)  1/215 (0.47%) 
Neck pain * 2  10/217 (4.61%)  10/215 (4.65%) 
Osteoarthritis * 2  0/217 (0.00%)  1/215 (0.47%) 
Osteonecrosis * 2  1/217 (0.46%)  0/215 (0.00%) 
Osteonecrosis of jaw * 2  1/217 (0.46%)  0/215 (0.00%) 
Pain in jaw * 2  2/217 (0.92%)  2/215 (0.93%) 
Tendon disorder * 2  1/217 (0.46%)  0/215 (0.00%) 
Tendonitis * 2  1/217 (0.46%)  2/215 (0.93%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Fibroma * 2  1/217 (0.46%)  0/215 (0.00%) 
Infected neoplasm * 2  0/217 (0.00%)  1/215 (0.47%) 
Malignant pleural effusion * 2  1/217 (0.46%)  0/215 (0.00%) 
Skin neoplasm bleeding * 2  0/217 (0.00%)  1/215 (0.47%) 
Thyroid neoplasm * 2  0/217 (0.00%)  1/215 (0.47%) 
Tumour pain * 2  3/217 (1.38%)  2/215 (0.93%) 
Tumour ulceration * 2  1/217 (0.46%)  0/215 (0.00%) 
Uterine leiomyoma * 2  0/217 (0.00%)  1/215 (0.47%) 
Nervous system disorders     
Dizziness * 1  14/217 (6.45%)  9/215 (4.19%) 
Dysgeusia * 1  58/217 (26.73%)  18/215 (8.37%) 
Headache * 1  57/217 (26.27%)  32/215 (14.88%) 
Neuropathy peripheral * 1  9/217 (4.15%)  13/215 (6.05%) 
Paraesthesia * 1  15/217 (6.91%)  16/215 (7.44%) 
Peripheral sensory neuropathy * 1  16/217 (7.37%)  6/215 (2.79%) 
Balance disorder * 2  2/217 (0.92%)  0/215 (0.00%) 
Burning sensation * 2  2/217 (0.92%)  0/215 (0.00%) 
Cervical root pain * 2  0/217 (0.00%)  1/215 (0.47%) 
Cognitive disorder * 2  1/217 (0.46%)  1/215 (0.47%) 
Coma * 2  1/217 (0.46%)  0/215 (0.00%) 
Convulsion * 2  1/217 (0.46%)  0/215 (0.00%) 
Coordination abnormal * 2  1/217 (0.46%)  0/215 (0.00%) 
Dysaesthesia * 2  8/217 (3.69%)  8/215 (3.72%) 
Formication * 2  0/217 (0.00%)  1/215 (0.47%) 
Hemiparesis * 2  0/217 (0.00%)  1/215 (0.47%) 
Hyperaesthesia * 2  2/217 (0.92%)  0/215 (0.00%) 
Hypersomnia * 2  0/217 (0.00%)  2/215 (0.93%) 
Hypoaesthesia * 2  4/217 (1.84%)  6/215 (2.79%) 
Hypogeusia * 2  1/217 (0.46%)  0/215 (0.00%) 
Hypokinesia * 2  1/217 (0.46%)  0/215 (0.00%) 
Lethargy * 2  1/217 (0.46%)  0/215 (0.00%) 
Memory impairment * 2  2/217 (0.92%)  4/215 (1.86%) 
Migraine * 2  4/217 (1.84%)  2/215 (0.93%) 
Neuralgia * 2  1/217 (0.46%)  2/215 (0.93%) 
Neurotoxicity * 2  1/217 (0.46%)  0/215 (0.00%) 
Paresis * 2  1/217 (0.46%)  0/215 (0.00%) 
Peripheral motor neuropathy * 2  3/217 (1.38%)  2/215 (0.93%) 
Polyneuropathy * 2  3/217 (1.38%)  3/215 (1.40%) 
Presyncope * 2  1/217 (0.46%)  1/215 (0.47%) 
Radicular syndrome * 2  1/217 (0.46%)  0/215 (0.00%) 
Radiculitis lumbosacral * 2  0/217 (0.00%)  1/215 (0.47%) 
Sciatica * 2  0/217 (0.00%)  4/215 (1.86%) 
Sensory disturbance * 2  0/217 (0.00%)  1/215 (0.47%) 
Sensory loss * 2  0/217 (0.00%)  1/215 (0.47%) 
Somnolence * 2  9/217 (4.15%)  2/215 (0.93%) 
Speech disorder * 2  2/217 (0.92%)  0/215 (0.00%) 
Syncope * 2  2/217 (0.92%)  0/215 (0.00%) 
Transient ischaemic attack * 2  1/217 (0.46%)  0/215 (0.00%) 
Tremor * 2  1/217 (0.46%)  2/215 (0.93%) 
Trigeminal nerve disorder * 2  0/217 (0.00%)  1/215 (0.47%) 
VIIth nerve paralysis * 2  1/217 (0.46%)  0/215 (0.00%) 
VIth nerve paralysis * 2  0/217 (0.00%)  1/215 (0.47%) 
Psychiatric disorders     
Anxiety * 1  14/217 (6.45%)  10/215 (4.65%) 
Insomnia * 1  18/217 (8.29%)  20/215 (9.30%) 
Apathy * 2  1/217 (0.46%)  0/215 (0.00%) 
Confusional state * 2  4/217 (1.84%)  2/215 (0.93%) 
Delirium * 2  1/217 (0.46%)  0/215 (0.00%) 
Depressed mood * 2  2/217 (0.92%)  0/215 (0.00%) 
Depression * 2  4/217 (1.84%)  4/215 (1.86%) 
Disorientation * 2  1/217 (0.46%)  0/215 (0.00%) 
Emotional disorder * 2  0/217 (0.00%)  1/215 (0.47%) 
Emotional distress * 2  1/217 (0.46%)  0/215 (0.00%) 
Mental status changes * 2  0/217 (0.00%)  1/215 (0.47%) 
Mood altered * 2  2/217 (0.92%)  0/215 (0.00%) 
Nervousness * 2  1/217 (0.46%)  0/215 (0.00%) 
Restlessness * 2  0/217 (0.00%)  1/215 (0.47%) 
Sleep disorder * 2  0/217 (0.00%)  2/215 (0.93%) 
Stress * 2  0/217 (0.00%)  1/215 (0.47%) 
Renal and urinary disorders     
Azotaemia * 2  2/217 (0.92%)  2/215 (0.93%) 
Chromaturia * 2  4/217 (1.84%)  0/215 (0.00%) 
Dysuria * 2  6/217 (2.76%)  3/215 (1.40%) 
Haematuria * 2  3/217 (1.38%)  0/215 (0.00%) 
Hydronephrosis * 2  1/217 (0.46%)  1/215 (0.47%) 
Micturition urgency * 2  1/217 (0.46%)  0/215 (0.00%) 
Polyuria * 2  1/217 (0.46%)  0/215 (0.00%) 
Proteinuria * 2  1/217 (0.46%)  0/215 (0.00%) 
Renal colic * 2  1/217 (0.46%)  1/215 (0.47%) 
Renal failure * 2  1/217 (0.46%)  2/215 (0.93%) 
Renal pain * 2  1/217 (0.46%)  0/215 (0.00%) 
Urge incontinence * 2  0/217 (0.00%)  1/215 (0.47%) 
Urinary retention * 2  1/217 (0.46%)  0/215 (0.00%) 
Reproductive system and breast disorders     
Bartholin’s cyst * 2  0/217 (0.00%)  1/215 (0.47%) 
Breast discharge * 2  1/217 (0.46%)  0/215 (0.00%) 
Breast induration * 2  1/217 (0.46%)  0/215 (0.00%) 
Breast mass * 2  1/217 (0.46%)  0/215 (0.00%) 
Breast oedema * 2  2/217 (0.92%)  0/215 (0.00%) 
Breast pain * 2  8/217 (3.69%)  8/215 (3.72%) 
Breast swelling * 2  0/217 (0.00%)  1/215 (0.47%) 
Breast tenderness * 2  2/217 (0.92%)  0/215 (0.00%) 
Dysmenorrhoea * 2  1/217 (0.46%)  0/215 (0.00%) 
Endometrial hyperplasia * 2  0/217 (0.00%)  1/215 (0.47%) 
Menstruation irregular * 2  1/217 (0.46%)  0/215 (0.00%) 
Metrorrhagia * 2  5/217 (2.30%)  1/215 (0.47%) 
Ovarian cyst * 2  0/217 (0.00%)  1/215 (0.47%) 
Pelvic pain * 2  1/217 (0.46%)  2/215 (0.93%) 
Postmenopausal haemorrhage * 2  0/217 (0.00%)  1/215 (0.47%) 
Retracted nipple * 2  0/217 (0.00%)  1/215 (0.47%) 
Uterine haemorrhage * 2  0/217 (0.00%)  1/215 (0.47%) 
Vaginal haemorrhage * 2  1/217 (0.46%)  0/215 (0.00%) 
Vaginal inflammation * 2  1/217 (0.46%)  0/215 (0.00%) 
Vulvovaginal discomfort * 2  0/217 (0.00%)  1/215 (0.47%) 
Vulvovaginal dryness * 2  1/217 (0.46%)  1/215 (0.47%) 
Vulvovaginal pruritus * 2  1/217 (0.46%)  1/215 (0.47%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  30/217 (13.82%)  28/215 (13.02%) 
Dyspnoea * 1  31/217 (14.29%)  26/215 (12.09%) 
Epistaxis * 1  31/217 (14.29%)  10/215 (4.65%) 
Atelectasis * 2  2/217 (0.92%)  0/215 (0.00%) 
Bronchospasm * 2  1/217 (0.46%)  1/215 (0.47%) 
Chronic obstructive pulmonary disease * 2  0/217 (0.00%)  1/215 (0.47%) 
Dry throat * 2  0/217 (0.00%)  1/215 (0.47%) 
Dysphonia * 2  5/217 (2.30%)  2/215 (0.93%) 
Dyspnoea exertional * 2  5/217 (2.30%)  6/215 (2.79%) 
Emphysema * 2  1/217 (0.46%)  0/215 (0.00%) 
Haemoptysis * 2  1/217 (0.46%)  0/215 (0.00%) 
Hiccups * 2  1/217 (0.46%)  1/215 (0.47%) 
Hydrothorax * 2  3/217 (1.38%)  1/215 (0.47%) 
Hypoventilation * 2  0/217 (0.00%)  1/215 (0.47%) 
Hypoxia * 2  1/217 (0.46%)  0/215 (0.00%) 
Lung disorder * 2  0/217 (0.00%)  2/215 (0.93%) 
Lung infiltration * 2  1/217 (0.46%)  0/215 (0.00%) 
Nasal congestion * 2  2/217 (0.92%)  0/215 (0.00%) 
Nasal disorder * 2  0/217 (0.00%)  1/215 (0.47%) 
Nasal dryness * 2  4/217 (1.84%)  4/215 (1.86%) 
Nasal ulcer * 2  1/217 (0.46%)  0/215 (0.00%) 
Oropharyngeal blistering * 2  1/217 (0.46%)  1/215 (0.47%) 
Oropharyngeal pain * 2  6/217 (2.76%)  4/215 (1.86%) 
Orthopnoea * 2  0/217 (0.00%)  1/215 (0.47%) 
Painful respiration * 2  1/217 (0.46%)  0/215 (0.00%) 
Pleural effusion * 2  7/217 (3.23%)  6/215 (2.79%) 
Pleurisy * 2  0/217 (0.00%)  1/215 (0.47%) 
Pneumothorax * 2  0/217 (0.00%)  1/215 (0.47%) 
Productive cough * 2  1/217 (0.46%)  1/215 (0.47%) 
Pulmonary embolism * 2  2/217 (0.92%)  3/215 (1.40%) 
Pulmonary oedema * 2  0/217 (0.00%)  1/215 (0.47%) 
Rales * 2  1/217 (0.46%)  0/215 (0.00%) 
Respiration abnormal * 2  0/217 (0.00%)  1/215 (0.47%) 
Rhinitis allergic * 2  0/217 (0.00%)  1/215 (0.47%) 
Rhinorrhoea * 2  5/217 (2.30%)  8/215 (3.72%) 
Sinus disorder * 2  1/217 (0.46%)  0/215 (0.00%) 
Tachypnoea * 2  0/217 (0.00%)  1/215 (0.47%) 
Throat irritation * 2  1/217 (0.46%)  1/215 (0.47%) 
Tonsillar inflammation * 2  0/217 (0.00%)  1/215 (0.47%) 
Wheezing * 2  0/217 (0.00%)  2/215 (0.93%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  16/217 (7.37%)  12/215 (5.58%) 
Dry skin * 1  14/217 (6.45%)  16/215 (7.44%) 
Erythema * 1  15/217 (6.91%)  12/215 (5.58%) 
Nail disorder * 1  14/217 (6.45%)  19/215 (8.84%) 
Palmar—plantar erythrodysaesthesia syndrome * 1  118/217 (54.38%)  131/215 (60.93%) 
Rash * 1  18/217 (8.29%)  24/215 (11.16%) 
Skin fissures * 1  3/217 (1.38%)  12/215 (5.58%) 
Acne * 2  0/217 (0.00%)  1/215 (0.47%) 
Angioedema * 2  1/217 (0.46%)  0/215 (0.00%) 
Blister * 2  0/217 (0.00%)  2/215 (0.93%) 
Cold sweat * 2  1/217 (0.46%)  0/215 (0.00%) 
Dermatitis * 2  2/217 (0.92%)  1/215 (0.47%) 
Dermatitis acneiform * 2  0/217 (0.00%)  1/215 (0.47%) 
Dermatitis allergic * 2  0/217 (0.00%)  3/215 (1.40%) 
Dermatitis contact * 2  0/217 (0.00%)  1/215 (0.47%) 
Ecchymosis * 2  4/217 (1.84%)  0/215 (0.00%) 
Eczema * 2  3/217 (1.38%)  1/215 (0.47%) 
Exfoliative rash * 2  0/217 (0.00%)  2/215 (0.93%) 
Hair colour changes * 2  9/217 (4.15%)  0/215 (0.00%) 
Hyperhidrosis * 2  1/217 (0.46%)  0/215 (0.00%) 
Hyperkeratosis * 2  3/217 (1.38%)  1/215 (0.47%) 
Hyperkeratosis palmaris and plantaris * 2  0/217 (0.00%)  1/215 (0.47%) 
Hypertrichosis * 2  0/217 (0.00%)  1/215 (0.47%) 
Hypoaesthesia facial * 2  0/217 (0.00%)  1/215 (0.47%) 
Ingrowing nail * 2  1/217 (0.46%)  0/215 (0.00%) 
Lipoatrophy * 2  0/217 (0.00%)  1/215 (0.47%) 
Macule * 2  0/217 (0.00%)  1/215 (0.47%) 
Madarosis * 2  2/217 (0.92%)  0/215 (0.00%) 
Nail dystrophy * 2  0/217 (0.00%)  1/215 (0.47%) 
Nail toxicity * 2  0/217 (0.00%)  2/215 (0.93%) 
Night sweats * 2  1/217 (0.46%)  2/215 (0.93%) 
Onychoclasis * 2  0/217 (0.00%)  2/215 (0.93%) 
Onycholysis * 2  0/217 (0.00%)  3/215 (1.40%) 
Onychomadesis * 2  0/217 (0.00%)  1/215 (0.47%) 
Pain of skin * 2  0/217 (0.00%)  1/215 (0.47%) 
Palmar erythema * 2  1/217 (0.46%)  1/215 (0.47%) 
Papule * 2  1/217 (0.46%)  2/215 (0.93%) 
Petechiae * 2  1/217 (0.46%)  1/215 (0.47%) 
Photosensitivity reaction * 2  1/217 (0.46%)  2/215 (0.93%) 
Pigmentation disorder * 2  2/217 (0.92%)  0/215 (0.00%) 
Plantar erythema * 2  0/217 (0.00%)  2/215 (0.93%) 
Pruritus * 2  8/217 (3.69%)  7/215 (3.26%) 
Purpura * 2  2/217 (0.92%)  0/215 (0.00%) 
Rash erythematous * 2  0/217 (0.00%)  2/215 (0.93%) 
Rash generalised * 2  1/217 (0.46%)  0/215 (0.00%) 
Rash macular * 2  3/217 (1.38%)  1/215 (0.47%) 
Rash papular * 2  0/217 (0.00%)  1/215 (0.47%) 
Rash pruritic * 2  1/217 (0.46%)  1/215 (0.47%) 
Scab * 2  0/217 (0.00%)  1/215 (0.47%) 
Scar pain * 2  1/217 (0.46%)  1/215 (0.47%) 
Skin chapped * 2  0/217 (0.00%)  1/215 (0.47%) 
Skin depigmentation * 2  1/217 (0.46%)  0/215 (0.00%) 
Skin discolouration * 2  7/217 (3.23%)  2/215 (0.93%) 
Skin exfoliation * 2  6/217 (2.76%)  3/215 (1.40%) 
Skin hyperpigmentation * 2  2/217 (0.92%)  3/215 (1.40%) 
Skin hypopigmentation * 2  1/217 (0.46%)  0/215 (0.00%) 
Skin lesion * 2  2/217 (0.92%)  0/215 (0.00%) 
Skin odour abnormal * 2  0/217 (0.00%)  1/215 (0.47%) 
Skin plaque * 2  0/217 (0.00%)  1/215 (0.47%) 
Skin reaction * 2  1/217 (0.46%)  2/215 (0.93%) 
Skin toxicity * 2  1/217 (0.46%)  2/215 (0.93%) 
Skin ulcer * 2  2/217 (0.92%)  1/215 (0.47%) 
Stasis dermatitis * 2  0/217 (0.00%)  1/215 (0.47%) 
Subcutaneous nodule * 2  1/217 (0.46%)  0/215 (0.00%) 
Swelling face * 2  1/217 (0.46%)  0/215 (0.00%) 
Urticaria * 2  2/217 (0.92%)  1/215 (0.47%) 
Xeroderma * 2  1/217 (0.46%)  0/215 (0.00%) 
Yellow skin * 2  9/217 (4.15%)  0/215 (0.00%) 
Social circumstances     
Inadequate diet * 2  1/217 (0.46%)  0/215 (0.00%) 
Surgical and medical procedures     
Breast reconstruction * 2  0/217 (0.00%)  1/215 (0.47%) 
Tooth extraction * 2  1/217 (0.46%)  1/215 (0.47%) 
Vascular disorders     
Hot flush * 1  11/217 (5.07%)  6/215 (2.79%) 
Hypertension * 1  46/217 (21.20%)  8/215 (3.72%) 
Capillary fragility * 2  1/217 (0.46%)  0/215 (0.00%) 
Circulatory collapse * 2  1/217 (0.46%)  0/215 (0.00%) 
Deep vein thrombosis * 2  2/217 (0.92%)  4/215 (1.86%) 
Flushing * 2  0/217 (0.00%)  1/215 (0.47%) 
Haematoma * 2  6/217 (2.76%)  0/215 (0.00%) 
Hyperaemia * 2  2/217 (0.92%)  0/215 (0.00%) 
Hypotension * 2  1/217 (0.46%)  9/215 (4.19%) 
Intermittent claudication * 2  1/217 (0.46%)  0/215 (0.00%) 
Lymphoedema * 2  3/217 (1.38%)  10/215 (4.65%) 
Orthostatic hypotension * 2  1/217 (0.46%)  0/215 (0.00%) 
Pallor * 2  1/217 (0.46%)  3/215 (1.40%) 
Phlebitis * 2  1/217 (0.46%)  2/215 (0.93%) 
Superior vena cava syndrome * 2  1/217 (0.46%)  0/215 (0.00%) 
Thrombosis * 2  2/217 (0.92%)  0/215 (0.00%) 
Trousseau’s syndrome * 2  1/217 (0.46%)  1/215 (0.47%) 
Vasoconstriction * 2  1/217 (0.46%)  0/215 (0.00%) 
Venous insufficiency * 2  0/217 (0.00%)  1/215 (0.47%) 
Venous thrombosis limb * 2  0/217 (0.00%)  1/215 (0.47%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MedDRA 14.0
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00435409    
Other Study ID Numbers: A6181099
First Submitted: February 13, 2007
First Posted: February 15, 2007
Results First Submitted: December 14, 2010
Results First Posted: January 13, 2011
Last Update Posted: June 26, 2012