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Study of Cabozantinib (XL184) in Adults With Advanced Malignancies

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: NCT00940225
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : April 25, 2024
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
Exelixis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Solid Tumors
Cancer
Interventions Drug: Cabozantinib
Drug: Placebo
Enrollment 730
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RDT Cohort - Castration-Resistant Prostate Cancer (CRPC) RDT Cohort - Melanoma RDT Cohort - Non-Small Cell Lung Cancer (NSCLC) RDT Cohort - Pancreatic Cancer RDT Cohort - Gastric/Gastroesophageal Junction Cancer (GEJ) RDT Cohort - Hepatocellular Carcinoma (HCC) RDT Cohort - Small Cell Lung Cancer (SCLC) RDT Cohort - Ovarian Cancer RDT Cohort - Metastatic Breast Cancer (MBC) NRE Cohort - CRPC 100 mg NRE Cohort - CRPC 39.4 mg NRE Cohort - Ovarian Cancer 100mg
Hide Arm/Group Description Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Subjects received a single oral daily dose of cabozantinib at 100 mg. Subjects received a single oral daily dose of cabozantinib at 39.4 mg. Subjects received a single oral daily dose of cabozantinib at 100 mg.
Period Title: Overall Study
Started 171 77 60 20 21 41 21 70 45 93 51 60
Completed 156 66 47 16 19 36 20 60 41 87 48 54
Not Completed 15 11 13 4 2 5 1 10 4 6 3 6
Arm/Group Title RDT Cohort - CRPC RDT Cohort - Melanoma RDT Cohort - NSCLC RDT Cohort - Pancreatic Cancer RDT Cohort - GEJ RDT Cohort - HCC RDT Cohort - SCLC RDT Cohort - Ovarian Cancer RDT Cohort - MBC NRE Cohort - CRPC 100 mg NRE Cohort - CRPC 39.4 mg NRE Cohort - Ovarian Cancer 100mg Total
Hide Arm/Group Description Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Eligible subjects with advanced solid tumors received open-label cabozantinib at a starting daily dose of 100 mg (freebase weight). Subjects received a single oral daily dose of cabozantinib at 100 mg. subjects received a single oral daily dose of cabozantinib at 39.4 mg. subjects received a single oral daily dose of cabozantinib at 100 mg. Total of all reporting groups
Overall Number of Baseline Participants 171 77 60 20 21 41 21 70 45 93 51 60 730
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 77 participants 60 participants 20 participants 21 participants 41 participants 21 participants 70 participants 45 participants 93 participants 51 participants 60 participants 730 participants
<= 40 years
0
   0.0%
5
   6.5%
1
   1.7%
1
   5.0%
1
   4.8%
4
   9.8%
0
   0.0%
4
   5.7%
6
  13.3%
0
   0.0%
0
   0.0%
1
   1.7%
23
   3.2%
> 40 - <= 50 years
4
   2.3%
6
   7.8%
3
   5.0%
1
   5.0%
3
  14.3%
3
   7.3%
2
   9.5%
12
  17.1%
7
  15.6%
3
   3.2%
5
   9.8%
10
  16.7%
59
   8.1%
> 50 - <= 65 years
60
  35.1%
28
  36.4%
23
  38.3%
11
  55.0%
9
  42.9%
22
  53.7%
12
  57.1%
32
  45.7%
26
  57.8%
41
  44.1%
24
  47.1%
33
  55.0%
321
  44.0%
> 65 years
107
  62.6%
38
  49.4%
33
  55.0%
7
  35.0%
8
  38.1%
12
  29.3%
7
  33.3%
22
  31.4%
6
  13.3%
49
  52.7%
22
  43.1%
16
  26.7%
327
  44.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 77 participants 60 participants 20 participants 21 participants 41 participants 21 participants 70 participants 45 participants 93 participants 51 participants 60 participants 730 participants
Female
0
   0.0%
35
  45.5%
27
  45.0%
7
  35.0%
5
  23.8%
10
  24.4%
12
  57.1%
70
 100.0%
44
  97.8%
0
   0.0%
0
   0.0%
60
 100.0%
270
  37.0%
Male
171
 100.0%
42
  54.5%
33
  55.0%
13
  65.0%
16
  76.2%
31
  75.6%
9
  42.9%
0
   0.0%
1
   2.2%
93
 100.0%
51
 100.0%
0
   0.0%
460
  63.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 77 participants 60 participants 20 participants 21 participants 41 participants 21 participants 70 participants 45 participants 93 participants 51 participants 60 participants 730 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
12
   7.0%
2
   2.6%
2
   3.3%
0
   0.0%
1
   4.8%
15
  36.6%
1
   4.8%
0
   0.0%
1
   2.2%
1
   1.1%
1
   2.0%
4
   6.7%
40
   5.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.1%
0
   0.0%
0
   0.0%
1
   0.1%
Black or African American
11
   6.4%
2
   2.6%
6
  10.0%
2
  10.0%
1
   4.8%
3
   7.3%
1
   4.8%
0
   0.0%
1
   2.2%
4
   4.3%
2
   3.9%
2
   3.3%
35
   4.8%
White
145
  84.8%
72
  93.5%
51
  85.0%
18
  90.0%
19
  90.5%
22
  53.7%
18
  85.7%
66
  94.3%
41
  91.1%
85
  91.4%
45
  88.2%
51
  85.0%
633
  86.7%
More than one race
3
   1.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   4.3%
1
   2.2%
1
   1.1%
0
   0.0%
1
   1.7%
9
   1.2%
Unknown or Not Reported
0
   0.0%
1
   1.3%
1
   1.7%
0
   0.0%
0
   0.0%
1
   2.4%
1
   4.8%
1
   1.4%
1
   2.2%
1
   1.1%
3
   5.9%
2
   3.3%
12
   1.6%
1.Primary Outcome
Title Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only
Hide Description

Objective response rate (ORR) per modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.0 per investigator

The analysis of ORR in the RDT Cohorts were defined as the proportion of subjects with a best overall response of confirmed complete response (CR) or partial response (PR) per mRECIST 1.0 during the 12-week Lead-In Stage.

In the NRE Ovarian Cohort, mRECIST 1.1 was used. ORR for the NRE CRPC Cohorts was not a primary objective and is therefore not captured in the table below.
Time Frame From initial dose through final study visit up to 44 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lead-in Stage - CRPC Lead-in Stage - Melanoma Lead-in Stage - NSCLC Lead-in Stage - Pancreatic Cancer Lead-in Stage - Gastric/GEJ Lead-in Stage - Hepatocellular Carcinoma Lead-in Stage - SCLC Lead-in Stage - Ovarian Cancer Lead-in Stage - Metastatic Breast Cancer Lead-in Stage - NRE Ovarian Cancer
Hide Arm/Group Description:
cabozantinib, 100 mg, po QD for 12 weeks
cabozantinib, 100 mg, po QD for 12 weeks
cabozantinib, 100 mg, po QD for 12 weeks
cabozantinib, 100 mg, po QD for 12 weeks
cabozantinib, 100 mg, po QD for 12 weeks
cabozantinib, 100 mg, po QD for 12 weeks
cabozantinib, 100 mg, po QD for 12 weeks
cabozantinib, 100 mg, po QD for 12 weeks
cabozantinib, 100 mg, po QD for 12 weeks
cabozantinib, 100 mg, po QD for 12 weeks
Overall Number of Participants Analyzed 171 77 60 20 21 41 21 70 45 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.7
(2.0 to 8.7)
5.2
(1.8 to 12.4)
10
(4.4 to 20.3)
0
(0 to 15.4)
4.8
(0.2 to 21.8)
4.9
(0.9 to 16.1)
4.8
(0.2 to 21.8)
21.7
(13.1 to 32.4)
13.6
(6.0 to 25.7)
10.0
(3.3 to 21.8)
2.Primary Outcome
Title Bone Scan Response (BSR) - NRE, CRPC
Hide Description The reduction of bone scan lesion area (BSLA) by > 30% was used as the quantitative measure of BSR. BSR was a primary outcome measure for only the NRE CRPC Cohorts.
Time Frame From initial dose through final study visit up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NRE Cohort - CRPC 100 mg NRE Cohort - CRPC 39.4 mg
Hide Arm/Group Description:
cabozantinib, 100 milligrams orally, daily for 12 weeks until progression or unacceptable toxicity.
cabozantinib, 39.4 milligrams orally, daily for 12 weeks until progression or unacceptable toxicity.
Overall Number of Participants Analyzed 93 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74.2
(64.1 to 82.7)
47.1
(32.9 to 61.5)
3.Primary Outcome
Title Progression-Free Survival (PFS) - Randomized Stage, RDT Cohorts Only
Hide Description Progression Free Survival during the Randomized Stage (Randomized Population)
Time Frame From initial dose through final study visit up to 44 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Randomized Phase - CRPC, Cabozantinib Arm Randomized Phase - CRPC, Placebo Arm Randomized Phase - Melanoma, Cabozantinib Arm Randomized Phase - Melanoma, Placebo Arm Randomized Phase - NSCLC, Cabozantinib Arm Randomized Phase - NSCLC, Placebo Arm Randomized Phase - Pancreatic Cancer, Cabozantinib Arm Randomized Phase - Pancreatic Cancer, Placebo Arm Randomized Phase - Gastric/GEJ, Cabozantinib Arm Randomized Phase - Gastric/GEJ , Placebo Arm Randomized Phase - HCC, Cabozantinib Arm Randomized Phase - HCC, Placebo Arm Randomized Phase - SCLC, Cabozantinib Arm Randomized Phase - SCLC, Placebo Arm Randomized Phase - Ovarian Cancer, Cabozantinib Arm Randomized Phase - Ovarian Cancer, Placebo Arm Randomized Phase - MBC, Cabozantinib Arm Randomized Phase - MBC, Placebo Arm
Hide Arm/Group Description:
cabozantinib, 100 mg, po QD, ongoing until progression
placebo 100mg, po QD, ongoing until progression
cabozantinib, 100 mg, po QD, ongoing until progression
Placebo, 100mg, po QD, ongoing until progression
cabozantinib, 100 mg, po QD, ongoing until progression
placebo, 100mg, po QD, ongoing until progression
cabozantinib, 100 mg, po QD, ongoing until progression
placebo, 100mg, po QD, ongoing until progression
cabozantinib, 100 mg, po QD, ongoing until progression
placebo, 100mg, po QD, ongoing until progression
cabozantinib, 100 mg, po QD, ongoing until progression
placebo, 100 mg, po QD, ongoing until progression
cabozantinib, 100 mg, po QD, ongoing until progression
placebo, 100 mg, po QD, ongoing until progression
cabozantinib, 100 mg, po QD, ongoing until progression
placebo, 100 mg, po QD, ongoing until progression
cabozantinib, 100 mg, po QD, ongoing until progression
placebo, 100 mg, po QD, ongoing until progression
Overall Number of Participants Analyzed 14 17 13 13 8 8 3 3 3 2 10 12 8 2 7 6 5 5
Median (95% Confidence Interval)
Unit of Measure: months
5.5
(4.0 to 8.5)
1.4
(1.25 to 2.73)
4.5
(1.8 to 15.4)
2.8
(1.45 to 5.45)
2.4
(1.3 to 2.9)
2.4
(1.4 to 2.7)
2.8
(1.5 to 2.8)
.07
(.07 to .07)
NA [1] 
(2.3 to NA)
1.0
(.72 to 1.38)
2.5
(1.3 to 6.8)
1.4
(1.3 to 4.2)
5.5
(1.9 to 6.9)
1.5
(.85 to 2.23)
4.9
(3.9 to 13.6)
1.4
(1.3 to 1.6)
6.9
(5.1 to 13.5)
1.1
(.7 to 1.3)
[1]
There was only one out of three subjects evaluated; unable to estimate due to insufficient number of patients within cohort.
4.Secondary Outcome
Title Duration of Objective Response (OR) - Responders From Lead-in Stage
Hide Description Duration of objective response was defined as the time from the tumor assessment that first documented PR or CR that was subsequently confirmed at least 28 days later until the date of documented progression. There were either few or no responders in the Gastric/GEJ, SCLC, and pancreatic cohorts so these cohorts are excluded.
Time Frame From initial dose through final study visit up to 44 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRPC Melanoma NSCLC Hepatocellular Carcinoma Ovarian Cancer Metastatic Breast Cancer
Hide Arm/Group Description:
cabozantinib, 100 mg, po QD ongoing until progression
cabozantinib, 100 mg, po QD ongoing until progression
cabozantinib, 100 mg, po QD ongoing until progression
cabozantinib, 100 mg, po QD ongoing until progression
cabozantinib, 100 mg, po QD ongoing until progression
cabozantinib, 100 mg, po QD ongoing until progression
Overall Number of Participants Analyzed 15 6 6 3 15 6
Median (95% Confidence Interval)
Unit of Measure: Months
5.59
(4.27 to 8.34)
5.55
(2.99 to 13.86)
6.90
(5.29 to 10.74)
4.21 [1] 
(2.99 to NA)
11.24 [1] 
(7.20 to NA)
3.29
(2.79 to 4.21)
[1]
Unable to estimate due to low numbers.
5.Secondary Outcome
Title Progression Free Survival (PFS) - Throughout the Study
Hide Description Progression-free survival (PFS) from first dose throughout the study was estimated for all subjects (safety population) using a piecewise method.
Time Frame From initial dose through final study visit up to 44 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRPC Melanoma NSCL Pancreatic Cancer Gastric/GEJ Hepatocellular Carcinoma SCLC Ovarian Cancer Metastatic Breast Cancer
Hide Arm/Group Description:
cabozantinib, 100 mg, po QD
cabozantinib, 100 mg, po QD
cabozantinib, 100 mg, po QD
cabozantinib, 100 mg, po QD
cabozantinib, 100 mg, po QD
cabozantinib, 100 mg, po QD
cabozantinib, 100 mg, po QD
cabozantinib, 100 mg, po QD
cabozantinib, 100 mg, po QD
Overall Number of Participants Analyzed 171 77 60 20 21 41 21 70 45
Median (Inter-Quartile Range)
Unit of Measure: months
6.8
(3.9 to 9.7)
2.8
(1.4 to 6.9)
4.0
(1.4 to 5.7)
2.7
(1.3 to 5.5)
1.4 [1] 
(1.3 to NA)
5.2
(3.6 to 9.3)
3.4
(1.4 to 8.2)
5.5
(2.7 to 11.0)
4.3
(1.4 to 8.1)
[1]
Unable to estimate as number of events is too low.
6.Secondary Outcome
Title Duration of Bone Scan Response - NRE Cohorts, CRPC Only
Hide Description The duration of BSR per IRF was calculated for CRPC subjects with an objective response (CR or PR) during the study.
Time Frame From initial dose through final study visit up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NRE Cohort - CRPC 100 mg NRE Cohort - CRPC 39.4 mg
Hide Arm/Group Description:
cabozantinib, 100 milligrams po QD for 12 weeks until progression or unacceptable toxicity.
cabozantinib, 39.4 milligrams po QD for 12 weeks until progression or unacceptable toxicity.
Overall Number of Participants Analyzed 69 24
Median (95% Confidence Interval)
Unit of Measure: months
5.2
(4.07 to 6.67)
NA [1] 
(NA to NA)
[1]
Unable to Estimate due to low numbers.
7.Secondary Outcome
Title Overall Survival (OS) - NRE Cohorts, CRPC and Ovarian Only
Hide Description [Not Specified]
Time Frame From initial dose through final study visit up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NRE Cohort - CRPC 100 mg NRE Cohort - CRPC 39.4 mg NRE Cohort - Ovarian 100 mg
Hide Arm/Group Description:
cabozantinib, 100 milligrams orally, daily for 12 weeks until progression or unacceptable toxicity.
cabozantinib, 39.4 milligrams orally, daily for 12 weeks until progression or unacceptable toxicity.
cabozantinib, 100 milligrams orally, daily for 12 weeks until progression or unacceptable toxicity.
Overall Number of Participants Analyzed 93 51 60
Median (95% Confidence Interval)
Unit of Measure: months
11.1
(9.17 to 13.34)
8.0 [1] 
(7.92 to NA)
8.5
(5.88 to 11.73)
[1]
Unable to Estimate due to low numbers.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RDT All Cohorts NRE Cohort - CRPC 100mg (Castration-Resistant Prostate Cancer) NRE Cohort - CRPC 39.4mg (Castration-Resistant Prostate Cancer) NRE Cohort - Ovarian 100mg
Hide Arm/Group Description Includes all tumor types from the 203 RDT cohort: castration-resistant prostate cancer (CRPC), melanoma, non-small cell lung cancer (NSCLC), pancreatic cancer, gastric/gastroesophageal junction (GEJ) cancer, hepatocellular carcinoma (HCC), small cell lung cancer (SCLC), ovarian cancer, and metastatic breast cancer Subjects received a single oral daily dose of cabozantinib at 100 mg. Subjects received a single oral daily dose of cabozantinib at 39.4 mg. Subjects received a single oral daily dose of cabozantinib at 100 mg.
All-Cause Mortality
RDT All Cohorts NRE Cohort - CRPC 100mg (Castration-Resistant Prostate Cancer) NRE Cohort - CRPC 39.4mg (Castration-Resistant Prostate Cancer) NRE Cohort - Ovarian 100mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   54/526 (10.27%)   53/93 (56.99%)   13/51 (25.49%)   33/60 (55.00%) 
Hide Serious Adverse Events
RDT All Cohorts NRE Cohort - CRPC 100mg (Castration-Resistant Prostate Cancer) NRE Cohort - CRPC 39.4mg (Castration-Resistant Prostate Cancer) NRE Cohort - Ovarian 100mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   223/526 (42.40%)   53/93 (56.99%)   30/51 (58.82%)   34/60 (56.67%) 
Blood and lymphatic system disorders         
Anaemia †  8/526 (1.52%)  4/93 (4.30%)  1/51 (1.96%)  0/60 (0.00%) 
Thrombocytopenia †  1/526 (0.19%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Disseminated Intravascular Coagulation †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Idiopathic Thrombocytopenic Purpura †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Cardiac disorders         
Acute Myocardial Infarction †  4/526 (0.76%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Angina Pectoris †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Atrial Fibrillation †  2/526 (0.38%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Atrioventricular Block †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Cardiac Arrest †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Cardiac Failure Congestive †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Cardiac Tamponade †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Coronary Artery Stenosis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Palpitations †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Pericardial Effusion †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Supraventricular Tachycardia †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Tachycardia †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Sinus Bradycardia †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Ear and labyrinth disorders         
Vertigo †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Endocrine disorders         
Adrenal Insufficiency †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Hypopituitarism †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Eye disorders         
Cataract †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Corneal Epithelium Defect †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Macular Oedema †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Parophthalmia †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Gastrointestinal disorders         
Abdominal Discomfort †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Abdominal Distension †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Abdominal Pain †  9/526 (1.71%)  2/93 (2.15%)  2/51 (3.92%)  7/60 (11.67%) 
Abdominal Pain Upper †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Anal Fissure †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Anal Ulcer †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Ascites †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Constipation †  4/526 (0.76%)  1/93 (1.08%)  0/51 (0.00%)  3/60 (5.00%) 
Diarrhoea †  15/526 (2.85%)  2/93 (2.15%)  0/51 (0.00%)  3/60 (5.00%) 
Diverticular Perforation †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Duodenal Ulcer Haemorrhage †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Dyspepsia †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Enterocutaneous Fistula †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Gastrointestinal Haemorrhage †  5/526 (0.95%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Gastroesophageal Reflux Disease †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Haematemesis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Haemorrhoids †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Inflammatory Bowel Disease †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Inguinal Hernia †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Intestinal Obstruction †  3/526 (0.57%)  0/93 (0.00%)  0/51 (0.00%)  4/60 (6.67%) 
Intestinal Perforation †  4/526 (0.76%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Lower Gastrointestinal Haemorrhage †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Melaena †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Nausea †  12/526 (2.28%)  9/93 (9.68%)  0/51 (0.00%)  8/60 (13.33%) 
Obstruction Gastric †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Oesophagitis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Pancreatitis †  2/526 (0.38%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Pancreatitis Acute †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Peritoneal Hemorrhage †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Pneumoperitoneum †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Proctalgia †  1/526 (0.19%)  1/93 (1.08%)  0/51 (0.00%)  1/60 (1.67%) 
Rectal Haemorrhage †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Rectal Obstruction †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Rectal Perforation †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Rectal Stenosis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Small Intestinal Obstruction †  5/526 (0.95%)  0/93 (0.00%)  0/51 (0.00%)  5/60 (8.33%) 
Vomiting †  15/526 (2.85%)  7/93 (7.53%)  0/51 (0.00%)  11/60 (18.33%) 
Abdominal Hernia †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Anal Fistula †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Colitis †  0/526 (0.00%)  2/93 (2.15%)  0/51 (0.00%)  0/60 (0.00%) 
Dysphagia †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Enterovesical Fistula †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Gastric Ulcer †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Ileus Paralytic †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Retroperitoneal Hematoma †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Upper Gastrointestinal Hemorrhage †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
General disorders         
Asthenia †  9/526 (1.71%)  1/93 (1.08%)  1/51 (1.96%)  0/60 (0.00%) 
Chest Pain †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Death †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Drug Withdrawal Syndrome †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Fatigue †  2/526 (0.38%)  5/93 (5.38%)  1/51 (1.96%)  1/60 (1.67%) 
General Physical Health Deterioration †  5/526 (0.95%)  0/93 (0.00%)  0/51 (0.00%)  3/60 (5.00%) 
Malaise †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Multi-Organ Failure †  4/526 (0.76%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Non-Cardiac Chest Pain †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Oedema Peripheral †  3/526 (0.57%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Pain †  2/526 (0.38%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Pyrexia †  5/526 (0.95%)  2/93 (2.15%)  0/51 (0.00%)  4/60 (6.67%) 
Acute Hepatic Failure †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Performance Status Decreased †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Hepatobiliary disorders         
Bile Duct Obstruction †  1/526 (0.19%)  0/93 (0.00%)  2/51 (3.92%)  0/60 (0.00%) 
Cholangitis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Cholecystitis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Cholestasis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Hepatic Failure †  5/526 (0.95%)  1/93 (1.08%)  0/51 (0.00%)  1/60 (1.67%) 
Hyperbilirubinemia †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Jaundice Cholestatic †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Portal Vein Thrombosis †  1/526 (0.19%)  2/93 (2.15%)  0/51 (0.00%)  0/60 (0.00%) 
Immune system disorders         
Anaphylactic Reaction †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Drug Hypersensitivity †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Infections and infestations         
Abscess Limb †  1/526 (0.19%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Bronchitis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Clostridium Difficile Colitis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Clostridium Difficile Infection †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Cystitis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Device Related Infection †  1/526 (0.19%)  1/93 (1.08%)  1/51 (1.96%)  0/60 (0.00%) 
Diverticulitis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Douglas' Abscess †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Empyema †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Escherichia Bacteremia †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Gastroenteritis Viral †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Herpes Oesophagitis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Klebsiella Bacteraemia †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Otitis Media †  1/526 (0.19%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Pelvic Abscess †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Perirectal Abscess †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Peritonitis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Pneumonia †  16/526 (3.04%)  3/93 (3.23%)  1/51 (1.96%)  0/60 (0.00%) 
Rectal Abscess †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Sepsis †  5/526 (0.95%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Septic Shock †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Staphylococcal Infection †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Staphylococcal Sepsis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Urinary Tract Infection †  7/526 (1.33%)  5/93 (5.38%)  0/51 (0.00%)  0/60 (0.00%) 
Urosepsis †  1/526 (0.19%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Wound Infection †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Wound Sepsis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Bacterial Sepsis †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  1/60 (1.67%) 
Cellulitis †  0/526 (0.00%)  2/93 (2.15%)  0/51 (0.00%)  0/60 (0.00%) 
Diabetic Foot Infection †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Lung Infection †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Osteomyelitis †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Pneumonia Fungal †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Tooth Infection †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Injury, poisoning and procedural complications         
Hip Fracture †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Laceration †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Radiation Pneumonitis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Rib Fracture †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Subdural Haematoma †  1/526 (0.19%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Wound Dehiscence †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Clavicle Fracture †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Spinal Compression Fracture †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Wrist Fracture †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Investigations         
Amylase Increased †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Aspartate Aminotransferase Increased †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Blood Uric Acid Increased †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Lipase Increased †  1/526 (0.19%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Alanine Aminotransferase Increased †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Blood Sodium Decreased †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Liver Function Test Abnormal †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Platelet Count Decreased †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Transaminases Increased †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Metabolism and nutrition disorders         
Decreased Appetite †  2/526 (0.38%)  0/93 (0.00%)  1/51 (1.96%)  2/60 (3.33%) 
Dehydration †  17/526 (3.23%)  6/93 (6.45%)  2/51 (3.92%)  0/60 (0.00%) 
Diabetic Ketoacidosis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Failure to Thrive †  3/526 (0.57%)  2/93 (2.15%)  0/51 (0.00%)  0/60 (0.00%) 
Gout †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Hypercalcaemia †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Hyperglycaemia †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Hypoglycaemia †  5/526 (0.95%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Hypokalaemia †  3/526 (0.57%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Hyponatraemia †  7/526 (1.33%)  2/93 (2.15%)  0/51 (0.00%)  2/60 (3.33%) 
Hyperkalaemia †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Malnutrition †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Musculoskeletal and connective tissue disorders         
Back Pain †  5/526 (0.95%)  5/93 (5.38%)  4/51 (7.84%)  0/60 (0.00%) 
Flank Pain †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Intervertebral Disc Protrusion †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Muscle Haemorrhage †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Muscular Weakness †  3/526 (0.57%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Osteonecrosis of Jaw †  1/526 (0.19%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Pain in Extremity †  1/526 (0.19%)  2/93 (2.15%)  1/51 (1.96%)  0/60 (0.00%) 
Pathological Fracture †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Arthralgia †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Bone Pain †  0/526 (0.00%)  6/93 (6.45%)  1/51 (1.96%)  0/60 (0.00%) 
Groin Pain †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Muscular Weakness †  0/526 (0.00%)  1/93 (1.08%)  1/51 (1.96%)  0/60 (0.00%) 
Musculoskeletal Chest Pain †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Neck Pain †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Rhabdomyolysis †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast Cancer †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Cancer Pain †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Intracranial Tumor Haemorrhage †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Malignant Melanoma †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Malignant Pleural Effusion †  4/526 (0.76%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Metastases to Central Nervous System †  1/526 (0.19%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Metastatic Pain †  2/526 (0.38%)  1/93 (1.08%)  1/51 (1.96%)  0/60 (0.00%) 
Non-Small Cell Lung Cancer †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Squamous Cell Carcinoma of the Oral Cavity †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Ovarian Cancer †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Prostate Cancer †  0/526 (0.00%)  3/93 (3.23%)  0/51 (0.00%)  0/60 (0.00%) 
Nervous system disorders         
Cerebral Haemorrhage †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Cerebrovascular Accident †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Convulsion †  3/526 (0.57%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Dizziness †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Encephalopathy †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Headache †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Hepatic Encephalopathy †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Occipital Neuralgia †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Presyncope †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Speech Disorder †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Spinal Cord Compression †  1/526 (0.19%)  1/93 (1.08%)  1/51 (1.96%)  0/60 (0.00%) 
Subdural Effusion †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Syncope †  3/526 (0.57%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Transient Ischaemic Attack †  3/526 (0.57%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
VIth Nerve Paralysis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Depressed Level of Consciousness †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Haemorrhage Intracranial †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Sciatica †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Psychiatric disorders         
Confusional State †  6/526 (1.14%)  2/93 (2.15%)  0/51 (0.00%)  1/60 (1.67%) 
Mental Status Change †  9/526 (1.71%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Anxiety †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Renal and urinary disorders         
Acute Prerenal Failure †  2/526 (0.38%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Haematuria †  3/526 (0.57%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Haemorrhage Urinary Tract †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Hydronephrosis †  3/526 (0.57%)  1/93 (1.08%)  1/51 (1.96%)  0/60 (0.00%) 
Renal Failure †  5/526 (0.95%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Renal Failure Acute †  11/526 (2.09%)  4/93 (4.30%)  0/51 (0.00%)  1/60 (1.67%) 
Ureteric Obstruction †  1/526 (0.19%)  0/93 (0.00%)  1/51 (1.96%)  0/60 (0.00%) 
Urethral Obstruction †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Urinary Tract Obstruction †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Reproductive system and breast disorders         
Vaginal Haemorrhage †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea †  8/526 (1.52%)  4/93 (4.30%)  1/51 (1.96%)  0/60 (0.00%) 
Epistaxis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Hypoxia †  1/526 (0.19%)  2/93 (2.15%)  0/51 (0.00%)  0/60 (0.00%) 
Pleural Effusion †  6/526 (1.14%)  1/93 (1.08%)  0/51 (0.00%)  1/60 (1.67%) 
Pneumonitis †  2/526 (0.38%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Pneumothorax †  3/526 (0.57%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Pulmonary Embolism †  23/526 (4.37%)  7/93 (7.53%)  8/51 (15.69%)  1/60 (1.67%) 
Pulmonary Thrombosis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Respiratory Distress †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Respiratory Failure †  7/526 (1.33%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Acute Respiratory Failure †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
Atelectasis †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Bronchopleural Fistula †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Chronic Obstructive Pulmonary Disease †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Pulmonary Alveolar Hemorrhage †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Skin and subcutaneous tissue disorders         
Decubitus Ulcer †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Palmar-Plantar Erythrodysaesthesia Syndrome †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Psoriasis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Rash †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Rash Pruritic †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Vascular disorders         
Deep Vein Thrombosis †  12/526 (2.28%)  1/93 (1.08%)  2/51 (3.92%)  0/60 (0.00%) 
Haemorrhage †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Hypertension †  3/526 (0.57%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Hypotension †  5/526 (0.95%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Hypovolaemic Shock †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Lymphoedema †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Orthostatic Hypotension †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Pelvic Venous Thrombosis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Venous Stenosis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Venous Thrombosis †  1/526 (0.19%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Bleeding Varicose Vein †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Haematoma †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  0/60 (0.00%) 
Venous Thrombosis Limb †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  1/60 (1.67%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RDT All Cohorts NRE Cohort - CRPC 100mg (Castration-Resistant Prostate Cancer) NRE Cohort - CRPC 39.4mg (Castration-Resistant Prostate Cancer) NRE Cohort - Ovarian 100mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   524/526 (99.62%)   93/93 (100.00%)   50/51 (98.04%)   59/60 (98.33%) 
Blood and lymphatic system disorders         
Anaemia †  63/526 (11.98%)  29/93 (31.18%)  5/51 (9.80%)  10/60 (16.67%) 
Leukopenia †  27/526 (5.13%)  7/93 (7.53%)  3/51 (5.88%)  5/60 (8.33%) 
Neutropenia †  35/526 (6.65%)  8/93 (8.60%)  3/51 (5.88%)  7/60 (11.67%) 
Thrombocytopenia †  58/526 (11.03%)  10/93 (10.75%)  3/51 (5.88%)  9/60 (15.00%) 
Cardiac disorders         
Tachycardia †  0/526 (0.00%)  2/93 (2.15%)  1/51 (1.96%)  3/60 (5.00%) 
Endocrine disorders         
Hypothyroidism †  66/526 (12.55%)  30/93 (32.26%)  4/51 (7.84%)  15/60 (25.00%) 
Eye disorders         
Vision Blurred †  0/526 (0.00%)  2/93 (2.15%)  4/51 (7.84%)  2/60 (3.33%) 
Dry Eye †  0/526 (0.00%)  1/93 (1.08%)  1/51 (1.96%)  3/60 (5.00%) 
Gastrointestinal disorders         
Abdominal Distension †  31/526 (5.89%)  4/93 (4.30%)  3/51 (5.88%)  10/60 (16.67%) 
Abdominal Pain Upper †  52/526 (9.89%)  6/93 (6.45%)  3/51 (5.88%)  7/60 (11.67%) 
Constipation †  168/526 (31.94%)  32/93 (34.41%)  16/51 (31.37%)  21/60 (35.00%) 
Diarrhoea †  314/526 (59.70%)  66/93 (70.97%)  23/51 (45.10%)  46/60 (76.67%) 
Dry Mouth †  87/526 (16.54%)  9/93 (9.68%)  4/51 (7.84%)  12/60 (20.00%) 
Dyspepsia †  63/526 (11.98%)  12/93 (12.90%)  7/51 (13.73%)  15/60 (25.00%) 
Dysphagia †  38/526 (7.22%)  5/93 (5.38%)  0/51 (0.00%)  8/60 (13.33%) 
Flatulence †  33/526 (6.27%)  8/93 (8.60%)  3/51 (5.88%)  5/60 (8.33%) 
Gastrooesophageal Reflux Disease †  45/526 (8.56%)  6/93 (6.45%)  5/51 (9.80%)  9/60 (15.00%) 
Glossodynia †  42/526 (7.98%)  2/93 (2.15%)  3/51 (5.88%)  2/60 (3.33%) 
Nausea †  269/526 (51.14%)  64/93 (68.82%)  30/51 (58.82%)  36/60 (60.00%) 
Oral Pain †  68/526 (12.93%)  11/93 (11.83%)  2/51 (3.92%)  4/60 (6.67%) 
Stomatitis †  99/526 (18.82%)  15/93 (16.13%)  5/51 (9.80%)  17/60 (28.33%) 
Vomiting †  188/526 (35.74%)  38/93 (40.86%)  19/51 (37.25%)  25/60 (41.67%) 
Abdominal Pain †  120/526 (22.81%)  17/93 (18.28%)  8/51 (15.69%)  23/60 (38.33%) 
Chest Pain †  0/526 (0.00%)  8/93 (8.60%)  3/51 (5.88%)  2/60 (3.33%) 
Proctalgia †  0/526 (0.00%)  5/93 (5.38%)  1/51 (1.96%)  0/60 (0.00%) 
Haemorrhoids †  0/526 (0.00%)  2/93 (2.15%)  2/51 (3.92%)  3/60 (5.00%) 
Hypoaesthesia Oral †  0/526 (0.00%)  1/93 (1.08%)  3/51 (5.88%)  0/60 (0.00%) 
Oesophagitis †  0/526 (0.00%)  1/93 (1.08%)  1/51 (1.96%)  4/60 (6.67%) 
Toothache †  0/526 (0.00%)  1/93 (1.08%)  1/51 (1.96%)  4/60 (6.67%) 
Abdominal Discomfort †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  4/60 (6.67%) 
Ascites †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  5/60 (8.33%) 
Early Satiety †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  3/60 (5.00%) 
General disorders         
Asthenia †  115/526 (21.86%)  18/93 (19.35%)  7/51 (13.73%)  10/60 (16.67%) 
Fatigue †  345/526 (65.59%)  76/93 (81.72%)  32/51 (62.75%)  47/60 (78.33%) 
Mucosal Inflammation †  84/526 (15.97%)  14/93 (15.05%)  8/51 (15.69%)  10/60 (16.67%) 
Oedema Peripheral †  76/526 (14.45%)  13/93 (13.98%)  11/51 (21.57%)  7/60 (11.67%) 
Pain †  36/526 (6.84%)  5/93 (5.38%)  6/51 (11.76%)  4/60 (6.67%) 
Pyrexia †  47/526 (8.94%)  6/93 (6.45%)  1/51 (1.96%)  3/60 (5.00%) 
Chills †  0/526 (0.00%)  5/93 (5.38%)  0/51 (0.00%)  5/60 (8.33%) 
Spinal Pain †  0/526 (0.00%)  5/93 (5.38%)  2/51 (3.92%)  0/60 (0.00%) 
Chest Discomfort †  0/526 (0.00%)  1/93 (1.08%)  3/51 (5.88%)  3/60 (5.00%) 
Infections and infestations         
Urinary Tract Infection †  59/526 (11.22%)  5/93 (5.38%)  4/51 (7.84%)  11/60 (18.33%) 
Upper Respiratory Tract Infection †  0/526 (0.00%)  4/93 (4.30%)  3/51 (5.88%)  2/60 (3.33%) 
Nasopharyngitis †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  5/60 (8.33%) 
Investigations         
Alanine Aminotransferase Increased †  71/526 (13.50%)  7/93 (7.53%)  3/51 (5.88%)  16/60 (26.67%) 
Aspartate Aminotransferase Increased †  94/526 (17.87%)  10/93 (10.75%)  5/51 (9.80%)  21/60 (35.00%) 
Lipase Increased †  35/526 (6.65%)  2/93 (2.15%)  1/51 (1.96%)  3/60 (5.00%) 
Weight Decreased †  165/526 (31.37%)  42/93 (45.16%)  19/51 (37.25%)  18/60 (30.00%) 
Platelet Count Decreased †  0/526 (0.00%)  5/93 (5.38%)  0/51 (0.00%)  2/60 (3.33%) 
Haemoglobin Decreased †  0/526 (0.00%)  5/93 (5.38%)  2/51 (3.92%)  0/60 (0.00%) 
Transaminases Increased †  0/526 (0.00%)  3/93 (3.23%)  0/51 (0.00%)  3/60 (5.00%) 
Blood Alkaline Phosphatase Increased †  0/526 (0.00%)  2/93 (2.15%)  3/51 (5.88%)  11/60 (18.33%) 
Blood Creatinine Increased †  0/526 (0.00%)  2/93 (2.15%)  3/51 (5.88%)  2/60 (3.33%) 
Gamma-Glutamyltransferase Increased †  0/526 (0.00%)  2/93 (2.15%)  1/51 (1.96%)  7/60 (11.67%) 
Blood Thyroid Stimulating Hormone Increased †  0/526 (0.00%)  1/93 (1.08%)  0/51 (0.00%)  4/60 (6.67%) 
Blood Albumin Decreased †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  3/60 (5.00%) 
Metabolism and nutrition disorders         
Decreased Appetite †  270/526 (51.33%)  70/93 (75.27%)  22/51 (43.14%)  31/60 (51.67%) 
Dehydration †  74/526 (14.07%)  17/93 (18.28%)  3/51 (5.88%)  9/60 (15.00%) 
Hypokalaemia †  62/526 (11.79%)  14/93 (15.05%)  6/51 (11.76%)  9/60 (15.00%) 
Hypomagnesaemia †  70/526 (13.31%)  6/93 (6.45%)  3/51 (5.88%)  12/60 (20.00%) 
Hyponatraemia †  25/526 (4.75%)  6/93 (6.45%)  3/51 (5.88%)  3/60 (5.00%) 
Hypophosphataemia †  41/526 (7.79%)  5/93 (5.38%)  3/51 (5.88%)  5/60 (8.33%) 
Hypocalcaemia †  0/526 (0.00%)  6/93 (6.45%)  2/51 (3.92%)  5/60 (8.33%) 
Hyperglycaemia †  0/526 (0.00%)  3/93 (3.23%)  1/51 (1.96%)  10/60 (16.67%) 
Hypoalbuminaemia †  0/526 (0.00%)  1/93 (1.08%)  1/51 (1.96%)  7/60 (11.67%) 
Musculoskeletal and connective tissue disorders         
Arthralgia †  39/526 (7.41%)  29/93 (31.18%)  6/51 (11.76%)  5/60 (8.33%) 
Back Pain †  74/526 (14.07%)  30/93 (32.26%)  11/51 (21.57%)  10/60 (16.67%) 
Muscle Spasms †  56/526 (10.65%)  10/93 (10.75%)  9/51 (17.65%)  13/60 (21.67%) 
Musculoskeletal Chest Pain †  27/526 (5.13%)  13/93 (13.98%)  3/51 (5.88%)  2/60 (3.33%) 
Musculoskeletal Pain †  34/526 (6.46%)  21/93 (22.58%)  7/51 (13.73%)  2/60 (3.33%) 
Myalgia †  36/526 (6.84%)  9/93 (9.68%)  1/51 (1.96%)  4/60 (6.67%) 
Pain in Extremity †  90/526 (17.11%)  29/93 (31.18%)  11/51 (21.57%)  9/60 (15.00%) 
Bone Pain †  0/526 (0.00%)  12/93 (12.90%)  6/51 (11.76%)  1/60 (1.67%) 
Muscular Weakness †  0/526 (0.00%)  13/93 (13.98%)  6/51 (11.76%)  0/60 (0.00%) 
Flank Pain †  0/526 (0.00%)  5/93 (5.38%)  1/51 (1.96%)  0/60 (0.00%) 
Neck Pain †  0/526 (0.00%)  4/93 (4.30%)  3/51 (5.88%)  0/60 (0.00%) 
Groin Pain †  0/526 (0.00%)  2/93 (2.15%)  3/51 (5.88%)  2/60 (3.33%) 
Nervous system disorders         
Dizziness †  86/526 (16.35%)  15/93 (16.13%)  7/51 (13.73%)  18/60 (30.00%) 
Dysgeusia †  156/526 (29.66%)  35/93 (37.63%)  14/51 (27.45%)  21/60 (35.00%) 
Headache †  79/526 (15.02%)  13/93 (13.98%)  8/51 (15.69%)  17/60 (28.33%) 
Neuropathy Peripheral †  38/526 (7.22%)  7/93 (7.53%)  0/51 (0.00%)  6/60 (10.00%) 
Peripheral Sensory Neuropathy †  0/526 (0.00%)  5/93 (5.38%)  2/51 (3.92%)  2/60 (3.33%) 
Hypoaesthesia †  0/526 (0.00%)  3/93 (3.23%)  5/51 (9.80%)  2/60 (3.33%) 
Syncope †  0/526 (0.00%)  2/93 (2.15%)  0/51 (0.00%)  3/60 (5.00%) 
Cognitive Disorder †  0/526 (0.00%)  1/93 (1.08%)  2/51 (3.92%)  3/60 (5.00%) 
Memory Impairment †  0/526 (0.00%)  2/93 (2.15%)  0/51 (0.00%)  4/60 (6.67%) 
Psychiatric disorders         
Anxiety †  34/526 (6.46%)  2/93 (2.15%)  1/51 (1.96%)  8/60 (13.33%) 
Confusional State †  35/526 (6.65%)  7/93 (7.53%)  0/51 (0.00%)  2/60 (3.33%) 
Depression †  38/526 (7.22%)  4/93 (4.30%)  2/51 (3.92%)  4/60 (6.67%) 
Insomnia †  44/526 (8.37%)  7/93 (7.53%)  2/51 (3.92%)  4/60 (6.67%) 
Sleep Disorder †  0/526 (0.00%)  0/93 (0.00%)  0/51 (0.00%)  3/60 (5.00%) 
Renal and urinary disorders         
Dysuria †  27/526 (5.13%)  3/93 (3.23%)  4/51 (7.84%)  4/60 (6.67%) 
Proteinuria †  34/526 (6.46%)  0/93 (0.00%)  0/51 (0.00%)  0/60 (0.00%) 
Pollakiuria †  0/526 (0.00%)  6/93 (6.45%)  3/51 (5.88%)  0/60 (0.00%) 
Haematuria †  0/526 (0.00%)  3/93 (3.23%)  6/51 (11.76%)  0/60 (0.00%) 
Urinary Incontinence †  0/526 (0.00%)  3/93 (3.23%)  4/51 (7.84%)  0/60 (0.00%) 
Micturition Urgency †  0/526 (0.00%)  0/93 (0.00%)  3/51 (5.88%)  1/60 (1.67%) 
Respiratory, thoracic and mediastinal disorders         
Cough †  88/526 (16.73%)  14/93 (15.05%)  3/51 (5.88%)  11/60 (18.33%) 
Dysphonia †  142/526 (27.00%)  34/93 (36.56%)  9/51 (17.65%)  16/60 (26.67%) 
Dyspnoea †  102/526 (19.39%)  29/93 (31.18%)  12/51 (23.53%)  11/60 (18.33%) 
Epistaxis †  36/526 (6.84%)  7/93 (7.53%)  1/51 (1.96%)  7/60 (11.67%) 
Oropharyngeal Pain †  60/526 (11.41%)  3/93 (3.23%)  4/51 (7.84%)  11/60 (18.33%) 
Pleural Effusion †  23/526 (4.37%)  7/93 (7.53%)  1/51 (1.96%)  3/60 (5.00%) 
Dyspnoea Exertional †  0/526 (0.00%)  5/93 (5.38%)  3/51 (5.88%)  2/60 (3.33%) 
Productive Cough †  0/526 (0.00%)  3/93 (3.23%)  0/51 (0.00%)  4/60 (6.67%) 
Skin and subcutaneous tissue disorders         
Alopecia †  43/526 (8.17%)  1/93 (1.08%)  0/51 (0.00%)  8/60 (13.33%) 
Dry Skin †  54/526 (10.27%)  6/93 (6.45%)  4/51 (7.84%)  7/60 (11.67%) 
Hair Colour Changes †  53/526 (10.08%)  4/93 (4.30%)  0/51 (0.00%)  8/60 (13.33%) 
Palmar-Plantar Erythrodysaesthesia Syndrome †  179/526 (34.03%)  24/93 (25.81%)  7/51 (13.73%)  20/60 (33.33%) 
Rash †  102/526 (19.39%)  19/93 (20.43%)  6/51 (11.76%)  12/60 (20.00%) 
Pruritus †  0/526 (0.00%)  4/93 (4.30%)  1/51 (1.96%)  3/60 (5.00%) 
Hyperhidrosis †  0/526 (0.00%)  1/93 (1.08%)  2/51 (3.92%)  3/60 (5.00%) 
Vascular disorders         
Hypertension †  126/526 (23.95%)  25/93 (26.88%)  10/51 (19.61%)  19/60 (31.67%) 
Hypotension †  0/526 (0.00%)  10/93 (10.75%)  2/51 (3.92%)  1/60 (1.67%) 
Pallor †  0/526 (0.00%)  7/93 (7.53%)  1/51 (1.96%)  0/60 (0.00%) 
Deep Vein Thrombosis †  0/526 (0.00%)  5/93 (5.38%)  2/51 (3.92%)  1/60 (1.67%) 
Hot Flush †  0/526 (0.00%)  5/93 (5.38%)  0/51 (0.00%)  2/60 (3.33%) 
Thrombosis †  0/526 (0.00%)  0/93 (0.00%)  1/51 (1.96%)  3/60 (5.00%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
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: Exelixis Medical Information
Organization: Exelixis, Inc.
Phone: 855-292-3935
EMail: druginfo@exelixis.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT00940225    
Other Study ID Numbers: XL184-203
First Submitted: July 12, 2009
First Posted: July 15, 2009
Results First Submitted: December 6, 2023
Results First Posted: April 25, 2024
Last Update Posted: April 25, 2024