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Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma (RESORCE)

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: NCT01774344
Recruitment Status : Completed
First Posted : January 24, 2013
Results First Posted : June 5, 2017
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Carcinoma, Hepatocellular
Interventions Drug: Regorafenib (Stivarga, BAY73-4506)
Drug: Placebo
Enrollment 573
Recruitment Details The study was conducted between 14 May 2013 (first subject first visit), 29 February 2016 (primary completion date) and 05-July-2019 (Last Patient Last Visit =End of study).
Pre-assignment Details Overall, 843 subjects were screened, of them 270 subjects were screening failures. 573 subjects were randomized and assigned to treatment; of them 6 subjects never received treatment. 436 Entered survival Follow-up and 4 End of survival follow-up data not available.
Arm/Group Title Placebo Regorafenib 160 mg (BAY73-4506)
Hide Arm/Group Description Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care. Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
Period Title: Overall Study
Started 194 379
Treated 193 374
Entered Survival FU 145 291
Completed 132 258
Not Completed 62 121
Reason Not Completed
Withdrawal by Subject             3             10
Protocol Violation             0             1
Lost to Follow-up             4             10
End of survival follow-up not available             2             2
Data collection finished             4             14
Other             0             1
Did not enter Survival Follow up             49             83
Arm/Group Title Placebo Regorafenib 160 mg (BAY73-4506) Total
Hide Arm/Group Description Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best supportive care (BSC). Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC. Total of all reporting groups
Overall Number of Baseline Participants 194 379 573
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 194 participants 379 participants 573 participants
61.1  (11.6) 61.8  (12.4) 61.6  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 379 participants 573 participants
Female
23
  11.9%
46
  12.1%
69
  12.0%
Male
171
  88.1%
333
  87.9%
504
  88.0%
Eastern cooperative oncology group (ECOG) Performance Status (PS) (data collection system-RAVE)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 379 participants 573 participants
ECOG PS 0
130
  67.0%
247
  65.2%
377
  65.8%
ECOG PS 1
64
  33.0%
132
  34.8%
196
  34.2%
[1]
Measure Description: ECOG PS was measured in a scale from 0 (best) to grade 4 (worst), where 0= Fully active, able to carry on all pre-diseases performance without restriction, 1= Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2= Ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50 percent (%) waking hours (h), 3= Capable of only limited self-care, confined to bed/chair, more than 50% waking hours, and 4= Completely disabled, cannot carry on any self-care, totally confined to bed/chair.
ECOG PS: Interactive voice response system (IVRS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 379 participants 573 participants
ECOG PS 0
129
  66.5%
251
  66.2%
380
  66.3%
ECOG PS 1
65
  33.5%
128
  33.8%
193
  33.7%
[1]
Measure Description: ECOG PS was measured in a scale from 0 (best) to grade 4 (worst), where 0= Fully active, able to carry on all pre-diseases performance without restriction, 1= Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2= Ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50 % waking h, 3= Capable of only limited self-care, confined to bed/chair, more than 50% waking hours, and 4= Completely disabled, cannot carry on any self-care, totally confined to bed/chair.
Alpha-fetoprotein (AFP) (RAVE)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 379 participants 573 participants
less than (<) 400 nanogram per milliliter (ng/mL)
107
  55.2%
217
  57.3%
324
  56.5%
greater than or equal to (>=) 400 ng/mL
87
  44.8%
162
  42.7%
249
  43.5%
[1]
Measure Description: Alpha-Fetoprotein blood test was performed and baseline data were reported.
Alpha-fetoprotein (AFP) (IVRS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 379 participants 573 participants
< 400 ng/mL
105
  54.1%
212
  55.9%
317
  55.3%
>= 400 ng/mL
89
  45.9%
167
  44.1%
256
  44.7%
[1]
Measure Description: AFP blood test was performed and baseline data were reported.
Macrovascular invasion (RAVE)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 379 participants 573 participants
Absence
140
  72.2%
269
  71.0%
409
  71.4%
Presence
54
  27.8%
110
  29.0%
164
  28.6%
[1]
Measure Description: Macrovascular invasion was defined as presence or absence of invasion of portal or hepatic vasculature by tumor.
Macrovascular invasion (IVRS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 379 participants 573 participants
Absence
135
  69.6%
262
  69.1%
397
  69.3%
Presence
59
  30.4%
117
  30.9%
176
  30.7%
[1]
Measure Description: Macrovascular invasion was defined as presence or absence of invasion of portal or hepatic vasculature by tumor.
The Barcelona-Clinic Liver Cancer (BCLC) stage at study entry   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 379 participants 573 participants
Early stage
0
   0.0%
1
   0.3%
1
   0.2%
Intermediate stage
22
  11.3%
53
  14.0%
75
  13.1%
Advanced stage
172
  88.7%
325
  85.8%
497
  86.7%
[1]
Measure Description: BCLC classification divides HCC subjects in 5 stages (0=very early stage, A=early stage, B=intermediate stage, C=advanced stage and D=terminal stage) according to pre-established prognostic variables, and allocates therapies according to treatment-related status. Thus, it provides information on both prognostic prediction and treatment allocation.
Extrahepatic disease (RAVE)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 379 participants 573 participants
Absence
47
  24.2%
114
  30.1%
161
  28.1%
Presence
147
  75.8%
265
  69.9%
412
  71.9%
[1]
Measure Description: Extrahepatic disease defined as presence or absence of tumor outside the liver.
Extrahepatic disease (IVRS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 379 participants 573 participants
Absence
62
  32.0%
129
  34.0%
191
  33.3%
Presence
132
  68.0%
250
  66.0%
382
  66.7%
[1]
Measure Description: Extrahepatic disease defined as presence or absence of tumor outside the liver.
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) was defined as the time from date of randomization (Day 1) to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time Frame From randomization (Day 1) of the first subject until 419 days later
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Regorafenib 160 mg (BAY73-4506)
Hide Arm/Group Description:
Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
Overall Number of Participants Analyzed 194 379
Median (95% Confidence Interval)
Unit of Measure: days
237
(192 to 269)
323
(276 to 369)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Hazard ratio for OS and 95% confidence interval was calculated for stratified IVRS by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.000017
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.624
Confidence Interval (2-Sided) 95%
0.498 to 0.782
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Hazard ratio for OS and 95% confidence interval was calculated for stratified RAVE (Sensitivity) by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.000149
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.660
Confidence Interval (2-Sided) 95%
0.527 to 0.828
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Hazard ratio for OS and 95% confidence interval was calculated for unstratified (sensitivity) by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.000107
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.674
Confidence Interval (2-Sided) 95%
0.546 to 0.831
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to Progression (TTP)
Hide Description TTP was the time (days) from randomization to radiological or clinical disease progression assessed by independent radiological review. Median and 95% confidence interval were reported for the modified response evaluation criteria in solid tumors (mRECIST) and response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) analysis sets. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time Frame From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Regorafenib 160 mg (BAY73-4506)
Hide Arm/Group Description:
Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
Overall Number of Participants Analyzed 194 379
Median (95% Confidence Interval)
Unit of Measure: days
mRECIST
45
(44 to 49)
97
(87 to 128)
RECIST 1.1
45
(44 to 49)
119
(87 to 128)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.000001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.439
Confidence Interval (2-Sided) 95%
0.355 to 0.542
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Hazard ratio and its 95% CI was based on unstratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.000001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.471
Confidence Interval (2-Sided) 95%
0.388 to 0.572
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.000001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.412
Confidence Interval (2-Sided) 95%
0.334 to 0.509
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Hazard ratio and its 95% CI was based on unstratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.000001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.444
Confidence Interval (2-Sided) 95%
0.365 to 0.539
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression Free Survival (PFS) was defined as the time (days) from date of randomization to date of disease progression (radiological or clinical) or death due to any cause, if death occurs before progression was documented. Death in the absence of progression was a PFS event only if it occurred within the 12+1 weeks for subjects who discontinued treatment prior to cycle 8 and 24+2 weeks for subjects who discontinued treatment after to cycle 8 of the last evaluable tumor assessment; PFS were censored at the date of the last evaluable tumor assessment, if it occurred later. Median and 95% confidence interval 95% were reported for the mRECIST and RECIST 1.1 analysis sets. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time Frame From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Regorafenib 160 mg (BAY73-4506)
Hide Arm/Group Description:
Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
Overall Number of Participants Analyzed 194 379
Median (95% Confidence Interval)
Unit of Measure: days
mRECIST
45
(44 to 47)
95
(86 to 127)
RECIST 1.1
45
(44 to 49)
102
(87 to 127)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.000001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.453
Confidence Interval (2-Sided) 95%
0.369 to 0.555
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.000001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.480
Confidence Interval (2-Sided) 95%
0.397 to 0.580
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.000001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.425
Confidence Interval (2-Sided) 95%
0.347 to 0.522
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.000001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.454
Confidence Interval (2-Sided) 95%
0.376 to 0.548
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Objective Tumor Response Rate (ORR)
Hide Description Objective tumor response rate (ORR) was defined as the percentage of subjects whose best tumor response CR or Partial Response (PR) observed during trial period assessed according to the mRECIST criteria and RECIST 1.1. CR= Disappearance of all clinical and radiological evidence of tumor (both target and non-target). Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non target lesions and no appearance of new lesions. Subjects prematurely discontinuing without an assessment were to be considered non-responders for the analysis.
Time Frame From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Regorafenib 160 mg (BAY73-4506)
Hide Arm/Group Description:
Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
Overall Number of Participants Analyzed 194 379
Measure Type: Number
Unit of Measure: percentage of subjects
mRECIST 4.1 10.8
RECIST 1.1 2.6 6.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Comparison of treatments were calculated.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.003650
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -6.88
Confidence Interval (2-Sided) 95%
-11.13 to -2.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Comparison of treatments were calculated.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.019991
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -4.15
Confidence Interval (2-Sided) 95%
-7.55 to -0.75
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description Disease control rate (DCR) was defined as the percentage of subjects whose best response was CR (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), PR (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or stable disease (SD) (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST and RECIST 1.1 criteria. SD had to be maintained for at least 6 weeks from the first demonstration of that rating.
Time Frame From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Regorafenib 160 mg (BAY73-4506)
Hide Arm/Group Description:
Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
Overall Number of Participants Analyzed 194 379
Measure Type: Number
Unit of Measure: percentage of subjects
mRECIST 36.1 65.2
RECIST 1.1 34.5 65.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Comparison of treatments were calculated.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.000001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -29.31
Confidence Interval (2-Sided) 95%
-37.52 to -21.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Regorafenib 160 mg (BAY73-4506)
Comments Comparison of treatments were calculated.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.000001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -31.39
Confidence Interval (2-Sided) 95%
-39.57 to -23.22
Estimation Comments [Not Specified]
6.Other Pre-specified Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) was defined as the time from date of randomization (Day 1) to death due to any cause
Time Frame From randomization (Day 1) of the first subject to end of follow upto 1710 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Regorafenib 160 mg (BAY73-4506)
Hide Arm/Group Description:
Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
Overall Number of Participants Analyzed 194 379
Median (95% Confidence Interval)
Unit of Measure: days
241
(196 to 274)
326
(278 to 372)
Time Frame Adverse event data were collected after start of study drug administration until 30 days after end of study treatment over a period of approximately three years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Regorafenib (Stivarga, BAY73-4506)
Hide Arm/Group Description Description: Subjects received placebo matched to regorafenib tablets orally every day for 3 weeks followed by 1 week off treatment plus best supportive care(BSC). Description: Subjects received regorafenib 160 mg (4 *40 mg tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
All-Cause Mortality
Placebo Regorafenib (Stivarga, BAY73-4506)
Affected / at Risk (%) Affected / at Risk (%)
Total   176/193 (91.19%)      324/374 (86.63%)    
Hide Serious Adverse Events
Placebo Regorafenib (Stivarga, BAY73-4506)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   92/193 (47.67%)      194/374 (51.87%)    
Blood and lymphatic system disorders     
Anaemia * 1  1/193 (0.52%)  3 4/374 (1.07%)  9
Thrombocytopenia * 1  0/193 (0.00%)  0 1/374 (0.27%)  7
Blood loss anaemia * 1  1/193 (0.52%)  2 0/374 (0.00%)  0
Cardiac disorders     
Acute coronary syndrome * 1  0/193 (0.00%)  0 4/374 (1.07%)  4
Atrial fibrillation * 1  0/193 (0.00%)  0 2/374 (0.53%)  2
Atrial flutter * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Cardiac arrest * 1  1/193 (0.52%)  2 0/374 (0.00%)  0
Myocardial infarction * 1  0/193 (0.00%)  0 2/374 (0.53%)  3
Acute myocardial infarction * 1  0/193 (0.00%)  0 2/374 (0.53%)  3
Angina unstable * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Cardiac failure acute * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Endocrine disorders     
Hypothyroidism * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Eye disorders     
Retinal artery occlusion * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Cataract * 1  0/193 (0.00%)  0 1/374 (0.27%)  2
Gastrointestinal disorders     
Abdominal discomfort * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Abdominal distension * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Abdominal pain * 1  4/193 (2.07%)  4 2/374 (0.53%)  3
Abdominal pain lower * 1  0/193 (0.00%)  0 2/374 (0.53%)  3
Abdominal pain upper * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Ascites * 1  6/193 (3.11%)  7 10/374 (2.67%)  13
Constipation * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Diarrhoea * 1  0/193 (0.00%)  0 3/374 (0.80%)  3
Diverticulum intestinal * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Dysphagia * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Duodenal perforation * 1  0/193 (0.00%)  0 1/374 (0.27%)  2
Gastritis * 1  1/193 (0.52%)  1 1/374 (0.27%)  1
Gastrointestinal haemorrhage * 1  2/193 (1.04%)  3 2/374 (0.53%)  2
Haematemesis * 1  1/193 (0.52%)  1 1/374 (0.27%)  1
Intra-abdominal haemorrhage * 1  2/193 (1.04%)  4 0/374 (0.00%)  0
Lower gastrointestinal haemorrhage * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Obstruction gastric * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Oesophageal haemorrhage * 1  1/193 (0.52%)  2 0/374 (0.00%)  0
Oesophageal varices haemorrhage * 1  1/193 (0.52%)  2 6/374 (1.60%)  6
Pancreatitis * 1  0/193 (0.00%)  0 3/374 (0.80%)  3
Pancreatitis acute * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Rectal haemorrhage * 1  0/193 (0.00%)  0 2/374 (0.53%)  2
Stomatitis * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Upper gastrointestinal haemorrhage * 1  3/193 (1.55%)  5 6/374 (1.60%)  6
Anal fistula * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Duodenal ulcer * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Peritoneal haemorrhage * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
General disorders     
Asthenia * 1  0/193 (0.00%)  0 4/374 (1.07%)  5
Death * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Fatigue * 1  0/193 (0.00%)  0 2/374 (0.53%)  3
General physical health deterioration * 1  25/193 (12.95%)  32 47/374 (12.57%)  73
Malaise * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Multiple organ dysfunction syndrome * 1  1/193 (0.52%)  2 0/374 (0.00%)  0
Pain * 1  2/193 (1.04%)  2 1/374 (0.27%)  1
Pyrexia * 1  1/193 (0.52%)  1 6/374 (1.60%)  6
Hepatobiliary disorders     
Acute hepatic failure * 1  0/193 (0.00%)  0 3/374 (0.80%)  5
Bile duct stenosis * 1  2/193 (1.04%)  5 0/374 (0.00%)  0
Cholecystitis * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Cholangitis * 1  1/193 (0.52%)  1 1/374 (0.27%)  2
Gallbladder obstruction * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Hepatic cirrhosis * 1  0/193 (0.00%)  0 2/374 (0.53%)  2
Hepatic failure * 1  9/193 (4.66%)  14 9/374 (2.41%)  14
Hepatic function abnormal * 1  3/193 (1.55%)  3 2/374 (0.53%)  2
Hepatic haemorrhage * 1  2/193 (1.04%)  4 2/374 (0.53%)  3
Hepatitis acute * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Hepatobiliary disease * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Hepatorenal syndrome * 1  1/193 (0.52%)  2 2/374 (0.53%)  3
Hyperbilirubinaemia * 1  1/193 (0.52%)  3 0/374 (0.00%)  0
Jaundice * 1  2/193 (1.04%)  2 1/374 (0.27%)  1
Jaundice cholestatic * 1  1/193 (0.52%)  1 2/374 (0.53%)  3
Portal vein thrombosis * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Cholangitis acute * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Infections and infestations     
Bronchitis * 1  0/193 (0.00%)  0 1/374 (0.27%)  3
Abdominal infection * 1  0/193 (0.00%)  0 2/374 (0.53%)  2
Candida infection * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Cellulitis * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Escherichia sepsis * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Gastroenteritis * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Liver abscess * 1  2/193 (1.04%)  2 2/374 (0.53%)  2
Lower respiratory tract infection * 1  0/193 (0.00%)  0 2/374 (0.53%)  5
Lung abscess * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Lung infection * 1  0/193 (0.00%)  0 4/374 (1.07%)  5
Peritonitis * 1  1/193 (0.52%)  1 1/374 (0.27%)  1
Peritonitis bacterial * 1  0/193 (0.00%)  0 1/374 (0.27%)  2
Pleural infection bacterial * 1  1/193 (0.52%)  2 0/374 (0.00%)  0
Pneumonia * 1  1/193 (0.52%)  1 8/374 (2.14%)  11
Sepsis * 1  0/193 (0.00%)  0 3/374 (0.80%)  5
Septic shock * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Streptococcal bacteraemia * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Subcutaneous abscess * 1  1/193 (0.52%)  3 1/374 (0.27%)  2
Tracheitis * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Urinary tract infection * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Urosepsis * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Wound infection bacterial * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Folliculitis * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Injury, poisoning and procedural complications     
Craniocerebral injury * 1  0/193 (0.00%)  0 1/374 (0.27%)  2
Femur fracture * 1  1/193 (0.52%)  1 1/374 (0.27%)  1
Pelvic fracture * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Pubis fracture * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Spinal compression fracture * 1  1/193 (0.52%)  1 1/374 (0.27%)  1
Investigations     
Aspartate aminotransferase increased * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Blood bilirubin increased * 1  2/193 (1.04%)  3 2/374 (0.53%)  3
Blood pressure decreased * 1  0/193 (0.00%)  0 1/374 (0.27%)  2
General physical condition abnormal * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Metabolism and nutrition disorders     
Decreased appetite * 1  3/193 (1.55%)  3 1/374 (0.27%)  3
Dehydration * 1  0/193 (0.00%)  0 4/374 (1.07%)  4
Hypercalcaemia * 1  2/193 (1.04%)  4 0/374 (0.00%)  0
Hyperglycaemia * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Hypoalbuminaemia * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Hypoglycaemia * 1  0/193 (0.00%)  0 2/374 (0.53%)  3
Hyponatraemia * 1  0/193 (0.00%)  0 2/374 (0.53%)  2
Malnutrition * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Back pain * 1  2/193 (1.04%)  2 6/374 (1.60%)  9
Bone pain * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Muscular weakness * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Musculoskeletal chest pain * 1  0/193 (0.00%)  0 1/374 (0.27%)  2
Musculoskeletal pain * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Myalgia * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Neck pain * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Pathological fracture * 1  1/193 (0.52%)  1 1/374 (0.27%)  1
Pain in extremity * 1  1/193 (0.52%)  2 1/374 (0.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma gastric * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Cancer pain * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Infected neoplasm * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Large intestine benign neoplasm * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Metastases to lung * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Thyroid neoplasm * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Tumour associated fever * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Tumour haemorrhage * 1  1/193 (0.52%)  2 0/374 (0.00%)  0
Tumour pain * 1  0/193 (0.00%)  0 4/374 (1.07%)  4
Nervous system disorders     
Brain oedema * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Cerebral haematoma * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Cerebrovascular accident * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Encephalopathy * 1  3/193 (1.55%)  4 3/374 (0.80%)  3
Epilepsy * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Haemorrhage intracranial * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Headache * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Hemiparesis * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Hepatic encephalopathy * 1  3/193 (1.55%)  6 9/374 (2.41%)  14
Meningorrhagia * 1  0/193 (0.00%)  0 1/374 (0.27%)  2
Myasthenia gravis * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Paraesthesia * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Quadriparesis * 1  0/193 (0.00%)  0 1/374 (0.27%)  2
Sciatica * 1  1/193 (0.52%)  2 0/374 (0.00%)  0
Seizure * 1  0/193 (0.00%)  0 2/374 (0.53%)  2
Status epilepticus * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Syncope * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Diplegia * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Intracranial pressure increased * 1  0/193 (0.00%)  0 1/374 (0.27%)  2
Intracranial venous sinus thrombosis * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Psychiatric disorders     
Anxiety * 1  0/193 (0.00%)  0 1/374 (0.27%)  2
Renal and urinary disorders     
Acute kidney injury * 1  2/193 (1.04%)  2 2/374 (0.53%)  2
Calculus urinary * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Cystitis noninfective * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Renal failure * 1  1/193 (0.52%)  1 3/374 (0.80%)  3
Ureterolithiasis * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Reproductive system and breast disorders     
Pelvic pain * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Scrotal oedema * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Respiratory, thoracic and mediastinal disorders     
Atelectasis * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Bronchial obstruction * 1  0/193 (0.00%)  0 1/374 (0.27%)  2
Dyspnoea * 1  2/193 (1.04%)  3 5/374 (1.34%)  7
Haemoptysis * 1  2/193 (1.04%)  2 3/374 (0.80%)  6
Interstitial lung disease * 1  0/193 (0.00%)  0 1/374 (0.27%)  2
Pleural effusion * 1  1/193 (0.52%)  2 4/374 (1.07%)  4
Pneumonia aspiration * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Pulmonary oedema * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Pneumonitis * 1  0/193 (0.00%)  0 2/374 (0.53%)  2
Respiratory distress * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Respiratory failure * 1  3/193 (1.55%)  6 1/374 (0.27%)  2
Tracheal disorder * 1  0/193 (0.00%)  0 1/374 (0.27%)  2
Cough * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Pulmonary venous thrombosis * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Skin and subcutaneous tissue disorders     
Blister * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Palmar-plantar erythrodysaesthesia syndrome * 1  0/193 (0.00%)  0 2/374 (0.53%)  3
Skin ulcer * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Precancerous skin lesion * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Vascular disorders     
Deep vein thrombosis * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
Embolism * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Hypovolaemic shock * 1  0/193 (0.00%)  0 1/374 (0.27%)  2
Hypertensive crisis * 1  0/193 (0.00%)  0 1/374 (0.27%)  1
Shock haemorrhagic * 1  0/193 (0.00%)  0 3/374 (0.80%)  5
Orthostatic hypotension * 1  1/193 (0.52%)  1 0/374 (0.00%)  0
1
Term from vocabulary, MedDRA (22.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Regorafenib (Stivarga, BAY73-4506)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   162/193 (83.94%)      366/374 (97.86%)    
Blood and lymphatic system disorders     
Anaemia * 1  21/193 (10.88%)  40 57/374 (15.24%)  114
Endocrine disorders     
Hypothyroidism * 1  1/193 (0.52%)  1 29/374 (7.75%)  33
Gastrointestinal disorders     
Abdominal distension * 1  10/193 (5.18%)  13 20/374 (5.35%)  24
Abdominal pain upper * 1  18/193 (9.33%)  22 52/374 (13.90%)  85
Abdominal pain * 1  29/193 (15.03%)  43 85/374 (22.73%)  127
Ascites * 1  31/193 (16.06%)  57 61/374 (16.31%)  91
Constipation * 1  21/193 (10.88%)  24 67/374 (17.91%)  79
Diarrhoea * 1  31/193 (16.06%)  44 163/374 (43.58%)  348
Dry mouth * 1  12/193 (6.22%)  15 22/374 (5.88%)  24
Nausea * 1  26/193 (13.47%)  38 72/374 (19.25%)  106
Stomatitis * 1  4/193 (2.07%)  4 31/374 (8.29%)  44
Vomiting * 1  13/193 (6.74%)  17 50/374 (13.37%)  73
General disorders     
Asthenia * 1  19/193 (9.84%)  34 56/374 (14.97%)  97
Fatigue * 1  50/193 (25.91%)  67 110/374 (29.41%)  205
Malaise * 1  5/193 (2.59%)  5 23/374 (6.15%)  33
Oedema peripheral * 1  26/193 (13.47%)  32 63/374 (16.84%)  81
Pyrexia * 1  13/193 (6.74%)  15 79/374 (21.12%)  113
Investigations     
Alanine aminotransferase increased * 1  21/193 (10.88%)  37 56/374 (14.97%)  102
Blood alkaline phosphatase increased * 1  9/193 (4.66%)  21 23/374 (6.15%)  43
Aspartate aminotransferase increased * 1  40/193 (20.73%)  89 99/374 (26.47%)  234
Blood bilirubin increased * 1  30/193 (15.54%)  59 94/374 (25.13%)  258
Gamma-glutamyltransferase increased * 1  14/193 (7.25%)  32 24/374 (6.42%)  73
Lipase increased * 1  7/193 (3.63%)  15 27/374 (7.22%)  62
Platelet count decreased * 1  2/193 (1.04%)  8 39/374 (10.43%)  129
Weight decreased * 1  9/193 (4.66%)  11 55/374 (14.71%)  132
White blood cell count decreased * 1  2/193 (1.04%)  7 20/374 (5.35%)  40
Metabolism and nutrition disorders     
Decreased appetite * 1  29/193 (15.03%)  37 122/374 (32.62%)  186
Hypoalbuminaemia * 1  14/193 (7.25%)  19 56/374 (14.97%)  152
Hypokalaemia * 1  6/193 (3.11%)  22 28/374 (7.49%)  62
Hyponatraemia * 1  7/193 (3.63%)  17 20/374 (5.35%)  30
Hypophosphataemia * 1  5/193 (2.59%)  11 36/374 (9.63%)  96
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  11/193 (5.70%)  12 15/374 (4.01%)  17
Back pain * 1  16/193 (8.29%)  18 50/374 (13.37%)  73
Musculoskeletal pain * 1  11/193 (5.70%)  19 18/374 (4.81%)  22
Muscle spasms * 1  4/193 (2.07%)  5 38/374 (10.16%)  48
Pain in extremity * 1  5/193 (2.59%)  6 31/374 (8.29%)  51
Nervous system disorders     
Headache * 1  12/193 (6.22%)  12 25/374 (6.68%)  33
Psychiatric disorders     
Insomnia * 1  8/193 (4.15%)  8 30/374 (8.02%)  35
Renal and urinary disorders     
Proteinuria * 1  2/193 (1.04%)  6 34/374 (9.09%)  96
Respiratory, thoracic and mediastinal disorders     
Cough * 1  13/193 (6.74%)  15 45/374 (12.03%)  50
Dyspnoea * 1  15/193 (7.77%)  15 26/374 (6.95%)  42
Dysphonia * 1  5/193 (2.59%)  7 68/374 (18.18%)  85
Pleural effusion * 1  10/193 (5.18%)  11 13/374 (3.48%)  14
Skin and subcutaneous tissue disorders     
Alopecia * 1  6/193 (3.11%)  6 27/374 (7.22%)  27
Palmar-plantar erythrodysaesthesia syndrome * 1  15/193 (7.77%)  27 194/374 (51.87%)  554
Pruritus * 1  14/193 (7.25%)  19 22/374 (5.88%)  34
Rash * 1  14/193 (7.25%)  15 21/374 (5.61%)  28
Vascular disorders     
Hypertension * 1  14/193 (7.25%)  30 119/374 (31.82%)  327
1
Term from vocabulary, MedDRA (22.0)
*
Indicates events were collected by non-systematic assessment
Decimal places were automatically truncated if last decimal equals zero.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Bayer AG
EMail: clinical-trials-contact@bayer.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01774344    
Other Study ID Numbers: 15982
2012-003649-14 ( EudraCT Number )
First Submitted: January 21, 2013
First Posted: January 24, 2013
Results First Submitted: February 9, 2017
Results First Posted: June 5, 2017
Last Update Posted: August 20, 2020