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A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00664326
Recruitment Status : Completed
First Posted : April 22, 2008
Results First Posted : November 28, 2012
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Renal Cell
Intervention Drug: Regorafenib (Stivarga, BAY73-4506)
Enrollment 49
Recruitment Details Male or female untreated participants, who were at least 18 years of age, with metastatic and/or unresectable, measurable predominantly clear cell renal cell cancer (RCC) histologically or cytologically documented could participate in this study at 18 centers in 6 countries.
Pre-assignment Details Of 64 enrolled participants, 49 received study medication, and 15 were screen failures due to protocol violation (12 participants), withdrawal of consent (1 participant), adverse event (2 participants).
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Period Title: Overall Study
Started 49
Completed 1 [1]
Not Completed 48
Reason Not Completed
Adverse Event             14
Noncompliance with study medication             3
Withdrawal by Subject             1
Physician Decision             1
Other Reasons             3
Death             2
Disease Progression/Recurrence/Relapse             24
[1]
transitioned to rollover study
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 49 participants
62.0
(40 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
22
  44.9%
Male
27
  55.1%
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
0
30
  61.2%
1
19
  38.8%
[1]
Measure Description: The ECOG PS ranged from Grades 0 to 5 (death). Grade 0 (fully active, able to carry on all pre-diseases performance without restriction) and Grade 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) were inclusion criteria.
Overall Motzer Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Low
24
  49.0%
Intermediate
25
  51.0%
[1]
Measure Description: The Motzer score (high/poor risk, intermediate risk, low risk) is based on the number of the following poor prognostic features a participant possessed: ECOG >2, serum lactate dehydrogenase concentration > 1.5 times the upper limit of normal, hemoglobin < lower limit of normal, corrected calcium concentration > 10 mg/dl, and absence of prior nephrectomy. Participants who had none of these features = low risk; participants with 1 or 2 of these features = intermediate risk; participants with 3 or more of these features = high/poor risk and were excluded from participating in the study.
1.Primary Outcome
Title Objective Tumor Response
Hide Description Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears] or Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline]) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) committee.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response (Primary analysis population)
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Percentage of participants
31.3
2.Primary Outcome
Title Tumor Response
Hide Description Tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears], Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline], Stable Disease [SD, steady state of disease], or Progressive Disease [PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions]) observed during trial period assessed according to the RECIST committee.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response (Primary analysis population)
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Percentage of participants
Complete Response (CR) 0.0
Partial Response (PR) 31.3
Stable Disease (SD) 50.0
Progressive Disease (PD) 10.4
Not Assessable 8.3
3.Secondary Outcome
Title Disease Control
Hide Description Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response (Primary analysis population)
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Percentage of participants
62.5
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) was calculated as the time from the first date of receiving study medication to death, due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009).
Hide Outcome Measure Data
Hide Analysis Population Description
intention-to-treat (ITT)
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 49
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(285 to NA)
[1]
Not estimable due to censored data.
5.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
intention-to-treat (ITT)
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 49
Median (95% Confidence Interval)
Unit of Measure: Days
251 [1] 
(160 to NA)
[1]
Not estimable due to censored data.
6.Secondary Outcome
Title Time to Progression (TTP)
Hide Description TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
intention-to-treat (ITT)
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 49
Median (95% Confidence Interval)
Unit of Measure: Days
251 [1] 
(167 to NA)
[1]
Not estimable due to censored data.
7.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects from ITT population with a response of CR or PR were included in this evaluation.
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 15
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(140 to NA)
[1]
Not estimable due to censored data.
8.Secondary Outcome
Title Duration of Stable Disease (SD)
Hide Description Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.
Time Frame From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: Days
172 [1] 
(107 to NA)
[1]
Not estimable due to censored data.
9.Other Pre-specified Outcome
Title Objective Tumor Response (Update)
Hide Description Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears] or Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline]) observed during trial period assessed according to the RECIST committee.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response (Primary analysis population)
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Percentage of participants
39.6
10.Other Pre-specified Outcome
Title Tumor Response (Update)
Hide Description Tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears], Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline], Stable Disease [SD, steady state of disease], or Progressive Disease [PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions]) observed during trial period assessed according to the RECIST committee.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response (Primary analysis population)
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Percentage of participants
Complete Response (CR) 0.0
Partial Response (PR) 39.6
Stable Disease (SD) 41.7
Progressive Disease (PD) 10.4
Not Assessable 8.3
11.Other Pre-specified Outcome
Title Disease Control (Update)
Hide Description Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response (Primary analysis population)
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Percentage of participants
62.5
12.Other Pre-specified Outcome
Title Overall Survival (Update)
Hide Description Overall survival (OS) was calculated as the time from the first date of receiving study medication to death, due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011).
Hide Outcome Measure Data
Hide Analysis Population Description
intention-to-treat (ITT)
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 49
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(735 to NA)
[1]
Not estimable due to censored data.
13.Other Pre-specified Outcome
Title Progression-free Survival (Update)
Hide Description PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
intention-to-treat (ITT)
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 49
Median (95% Confidence Interval)
Unit of Measure: Days
335
(167 to 438)
14.Other Pre-specified Outcome
Title Time to Progression (Update)
Hide Description TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
intention-to-treat (ITT)
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 49
Median (95% Confidence Interval)
Unit of Measure: Days
335
(167 to 454)
15.Other Pre-specified Outcome
Title Duration of Response (Update)
Hide Description Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects from ITT population with a response of CR or PR were included in this evaluation.
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: Days
428
(250 to 540)
16.Other Pre-specified Outcome
Title Duration of Stable Disease (Update)
Hide Description Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.
Time Frame From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects from ITT population who achieved objective response of CR or PR were excluded from this evaluation.
Arm/Group Title Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description:
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: Days
119
(105 to 335)
Time Frame [Not Specified]
Adverse Event Reporting Description Acronyms used in Adverse events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Common Terminology Criteria for Adverse Events (CTCAE).
 
Arm/Group Title Regorafenib (BAY73-4506)
Hide Arm/Group Description Subjects received regorafenib 160 mg po qd for 3 weeks of every 4 week cycle (3 weeks on, 1 week off).
All-Cause Mortality
Regorafenib (BAY73-4506)
Affected / at Risk (%)
Total   39/49 (79.59%)    
Hide Serious Adverse Events
Regorafenib (BAY73-4506)
Affected / at Risk (%) # Events
Total   32/49 (65.31%)    
Cardiac disorders   
Angina unstable * 1  1/49 (2.04%)  2
Atrial fibrillation * 1  1/49 (2.04%)  1
Cardiac arrest * 1  2/49 (4.08%)  2
Myocardial infarction * 1  2/49 (4.08%)  2
Gastrointestinal disorders   
Abdominal pain * 1  1/49 (2.04%)  1
Diarrhoea * 1  1/49 (2.04%)  1
Gastrointestinal pain * 1  1/49 (2.04%)  1
Haematemesis * 1  1/49 (2.04%)  1
Small intestinal obstruction * 1  1/49 (2.04%)  1
Vomiting * 1  1/49 (2.04%)  1
General disorders   
Chest pain * 1  2/49 (4.08%)  2
Fatigue * 1  1/49 (2.04%)  1
Malaise * 1  1/49 (2.04%)  1
Pyrexia * 1  1/49 (2.04%)  1
General physical health deterioration * 1  2/49 (4.08%)  2
Hepatobiliary disorders   
Cholecystitis * 1  1/49 (2.04%)  2
Hepatic function abnormal * 1  1/49 (2.04%)  1
Bile duct obstruction * 1  1/49 (2.04%)  1
Infections and infestations   
Cellulitis * 1  1/49 (2.04%)  1
Infection * 1  1/49 (2.04%)  2
Pneumonia * 1  1/49 (2.04%)  1
Sepsis * 1  1/49 (2.04%)  2
Injury, poisoning and procedural complications   
Fracture * 1  1/49 (2.04%)  3
Humerus fracture * 1  1/49 (2.04%)  1
Procedural intestinal perforation * 1  1/49 (2.04%)  2
Investigations   
Haemoglobin decreased * 1  1/49 (2.04%)  2
Metabolism and nutrition disorders   
Hypocalcaemia * 1  1/49 (2.04%)  1
Hypomagnesaemia * 1  1/49 (2.04%)  1
Hypovolaemia * 1  1/49 (2.04%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/49 (2.04%)  1
Back pain * 1  1/49 (2.04%)  1
Flank pain * 1  1/49 (2.04%)  2
Muscular weakness * 1  1/49 (2.04%)  1
Musculoskeletal pain * 1  1/49 (2.04%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bone neoplasm * 1  1/49 (2.04%)  1
Metastases to spine * 1  1/49 (2.04%)  1
Ovarian adenoma * 1  1/49 (2.04%)  1
Nervous system disorders   
Loss of consciousness * 1  1/49 (2.04%)  1
Sciatica * 1  1/49 (2.04%)  1
Syncope * 1  2/49 (4.08%)  3
Renal and urinary disorders   
Renal failure * 1  4/49 (8.16%)  7
Acute kidney injury * 1  1/49 (2.04%)  2
Reproductive system and breast disorders   
Ovarian cyst * 1  1/49 (2.04%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis * 1  1/49 (2.04%)  2
Haemoptysis * 1  1/49 (2.04%)  1
Laryngospasm * 1  1/49 (2.04%)  1
Pleural effusion * 1  2/49 (4.08%)  2
Pulmonary embolism * 1  1/49 (2.04%)  1
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysaesthesia syndrome * 1  1/49 (2.04%)  2
Rash * 1  1/49 (2.04%)  1
Rash generalised * 1  1/49 (2.04%)  1
Surgical and medical procedures   
Tumour excision * 1  1/49 (2.04%)  1
Vascular disorders   
Circulatory collapse * 1  1/49 (2.04%)  1
1
Term from vocabulary, MedDRA (21.1)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Regorafenib (BAY73-4506)
Affected / at Risk (%) # Events
Total   48/49 (97.96%)    
Blood and lymphatic system disorders   
Anaemia * 1  5/49 (10.20%)  9
Thrombocytopenia * 1  5/49 (10.20%)  11
Gastrointestinal disorders   
Abdominal pain * 1  13/49 (26.53%)  37
Abdominal pain upper * 1  8/49 (16.33%)  28
Constipation * 1  17/49 (34.69%)  112
Diarrhoea * 1  24/49 (48.98%)  215
Dyspepsia * 1  6/49 (12.24%)  7
Dysphagia * 1  4/49 (8.16%)  5
Glossodynia * 1  3/49 (6.12%)  4
Nausea * 1  16/49 (32.65%)  46
Oral pain * 1  6/49 (12.24%)  35
Stomatitis * 1  15/49 (30.61%)  108
Vomiting * 1  13/49 (26.53%)  29
General disorders   
Chest pain * 1  7/49 (14.29%)  19
Chills * 1  3/49 (6.12%)  6
Fatigue * 1  22/49 (44.90%)  192
Mucosal inflammation * 1  6/49 (12.24%)  11
Oedema peripheral * 1  4/49 (8.16%)  13
Pain * 1  6/49 (12.24%)  31
Pyrexia * 1  9/49 (18.37%)  14
Infections and infestations   
Bronchitis * 1  3/49 (6.12%)  3
Infection * 1  3/49 (6.12%)  3
Nasopharyngitis * 1  9/49 (18.37%)  21
Oral candidiasis * 1  3/49 (6.12%)  7
Rhinitis * 1  4/49 (8.16%)  6
Upper respiratory tract infection * 1  4/49 (8.16%)  6
Urinary tract infection * 1  6/49 (12.24%)  13
Investigations   
Amylase increased * 1  4/49 (8.16%)  12
Blood creatinine increased * 1  3/49 (6.12%)  7
Lipase increased * 1  7/49 (14.29%)  29
Weight decreased * 1  8/49 (16.33%)  86
Metabolism and nutrition disorders   
Hyperuricaemia * 1  3/49 (6.12%)  13
Decreased appetite * 1  16/49 (32.65%)  104
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  7/49 (14.29%)  120
Back pain * 1  13/49 (26.53%)  55
Bone pain * 1  3/49 (6.12%)  25
Muscle spasms * 1  6/49 (12.24%)  53
Musculoskeletal pain * 1  8/49 (16.33%)  23
Neck pain * 1  4/49 (8.16%)  12
Pain in extremity * 1  11/49 (22.45%)  85
Nervous system disorders   
Ageusia * 1  3/49 (6.12%)  4
Dizziness * 1  4/49 (8.16%)  7
Dysgeusia * 1  4/49 (8.16%)  14
Headache * 1  14/49 (28.57%)  47
Neuropathy peripheral * 1  4/49 (8.16%)  8
Paraesthesia * 1  4/49 (8.16%)  61
Psychiatric disorders   
Insomnia * 1  6/49 (12.24%)  23
Respiratory, thoracic and mediastinal disorders   
Cough * 1  6/49 (12.24%)  15
Dysphonia * 1  18/49 (36.73%)  50
Dyspnoea * 1  16/49 (32.65%)  48
Epistaxis * 1  4/49 (8.16%)  6
Oropharyngeal pain * 1  3/49 (6.12%)  7
Skin and subcutaneous tissue disorders   
Alopecia * 1  22/49 (44.90%)  139
Dry skin * 1  6/49 (12.24%)  77
Hyperhidrosis * 1  5/49 (10.20%)  19
Night sweats * 1  4/49 (8.16%)  8
Palmar erythema * 1  3/49 (6.12%)  3
Palmar-plantar erythrodysaesthesia syndrome * 1  34/49 (69.39%)  402
Pruritus * 1  5/49 (10.20%)  16
Rash * 1  17/49 (34.69%)  74
Rash generalised * 1  3/49 (6.12%)  4
Vascular disorders   
Hypertension * 1  25/49 (51.02%)  338
1
Term from vocabulary, MedDRA (21.1)
*
Indicates events were collected by non-systematic assessment
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.

The agreed point of publication is 12-18 months after database lock at the earliest. Bayer will have 30-45 days to review publications, and may request an additional publication delay of up to 60 days to allow for filing a Patent Application (if applicable).

No publication of single center data should be done prior of publication if multi-center data.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00664326    
Other Study ID Numbers: 11726
2008-000107-28 ( EudraCT Number )
First Submitted: April 17, 2008
First Posted: April 22, 2008
Results First Submitted: October 28, 2012
Results First Posted: November 28, 2012
Last Update Posted: April 24, 2020