Trial Outcomes & Findings for Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer (NCT NCT01010126)

NCT ID: NCT01010126

Last Updated: 2019-01-25

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The 6-month progression free survival rate is the proportion of evaluable patients progression-free 6 months from registration. The 6-month progression-free rate is defined as the total number of efficacy evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of evaluable patients enrolled on study. Kaplan-Meier methodology will be used to estimate the final success proportion (i.e. progression free at 6 months with a 95% confidence interval).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 252 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-01-25

Participant Flow

Participant milestones

Measure	Endometrial Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Ovarian Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Hepatocellular Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Carcinoid Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Double Agent) Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Bevacizumab-only) Cohort Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	27	58	28	57	58	24
Overall Study COMPLETED	26	58	27	57	55	24
Overall Study NOT COMPLETED	1	0	1	0	3	0

Reasons for withdrawal

Measure	Endometrial Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Ovarian Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Hepatocellular Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Carcinoid Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Double Agent) Cohort Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Bevacizumab-only) Cohort Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study Withdrawal by Subject	1	0	1	0	3	0

Baseline Characteristics

Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer

Baseline characteristics by cohort

Measure	Endometrial Cohort n=26 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Ovarian Cohort n=58 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Hepatocellular Cohort n=27 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Carcinoid Cohort n=57 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Double Agent) Cohort n=58 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Bevacizumab-only) Cohort n=24 Participants Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Total n=250 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	62.5 years n=7 Participants	59 years n=5 Participants	62 years n=4 Participants	58.5 years n=21 Participants	54.5 years n=10 Participants	60 years n=115 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	58 Participants n=7 Participants	5 Participants n=5 Participants	31 Participants n=4 Participants	29 Participants n=21 Participants	10 Participants n=10 Participants	159 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	22 Participants n=5 Participants	26 Participants n=4 Participants	29 Participants n=21 Participants	14 Participants n=10 Participants	91 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	11 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	54 Participants n=7 Participants	25 Participants n=5 Participants	54 Participants n=4 Participants	57 Participants n=21 Participants	22 Participants n=10 Participants	231 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	8 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	8 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	8 Participants n=21 Participants	3 Participants n=10 Participants	24 Participants n=115 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	49 Participants n=7 Participants	22 Participants n=5 Participants	49 Participants n=4 Participants	50 Participants n=21 Participants	20 Participants n=10 Participants	212 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants
Region of Enrollment Canada	5 participants n=5 Participants	34 participants n=7 Participants	8 participants n=5 Participants	2 participants n=4 Participants	14 participants n=21 Participants	0 participants n=10 Participants	63 participants n=115 Participants
Region of Enrollment United States	21 participants n=5 Participants	24 participants n=7 Participants	19 participants n=5 Participants	55 participants n=4 Participants	44 participants n=21 Participants	24 participants n=10 Participants	187 participants n=115 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All patients that received study treatment and were evaluated for response are included in this analysis

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The 6-month progression free survival rate is the proportion of evaluable patients progression-free 6 months from registration. The 6-month progression-free rate is defined as the total number of efficacy evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of evaluable patients enrolled on study. Kaplan-Meier methodology will be used to estimate the final success proportion (i.e. progression free at 6 months with a 95% confidence interval).

Outcome measures

Measure	Endometrial Cohort n=26 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Ovarian Cohort n=58 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Hepatocellular Cohort n=27 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Carcinoid Cohort n=55 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Double Agent) Cohort n=54 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Bevacizumab-only) Cohort n=24 Participants Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Progression Free Survival Rate	0.52 proportion of patients Interval 0.35 to 0.77	0.40 proportion of patients Interval 0.29 to 0.55	0.71 proportion of patients Interval 0.54 to 0.94	0.84 proportion of patients Interval 0.75 to 0.95	0.85 proportion of patients Interval 0.75 to 0.95	0.87 proportion of patients Interval 0.74 to 1.0

PRIMARY outcome

Timeframe: Up to 3 years

Population: For this analysis, the number of patients that had a best response of CR or PR were divided by the number of patients evaluated for a response.

Tumor response rate defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of efficacy evaluable patients enrolled on study. Patients were evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. In brief, a Complete Response (CR) means the complete disappearance of all target lesions and a reduction in each lymph node to <1 cm. A Partial Response (PR) is defined as a 30% decrease in the sum of the longest diameter of the non-nodal target lesion from baseline. Each requires no new lesions present at evaluation. The proportion of participants with a response is provided here for each cohort. The proportion was calculated as the number of patients that had a best response of CR or PR divided by the number of patients evaluated for a response in each cohort.

Outcome measures

Measure	Endometrial Cohort n=26 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Ovarian Cohort n=58 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Hepatocellular Cohort n=27 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Carcinoid Cohort n=57 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Double Agent) Cohort n=58 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Bevacizumab-only) Cohort n=24 Participants Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Tumor Response Rate	0.31 proportion of participants Interval 0.14 to 0.52	0.31 proportion of participants Interval 0.2 to 0.45	0.19 proportion of participants Interval 0.06 to 0.38	0.12 proportion of participants Interval 0.05 to 0.24	0.40 proportion of participants Interval 0.27 to 0.53	0.17 proportion of participants Interval 0.05 to 0.37

SECONDARY outcome

Timeframe: Time from date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 3 years

Population: All patients that were assessed as a Complete Response or Partial Response were included in this analysis.

Duration of response is defined for all evaluable patients who have achieved a response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Objective response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) as described in Primary Objective 2 in this report. Median duration of response and the confidence interval for the median duration will be computed.

Outcome measures

Measure	Endometrial Cohort n=8 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Ovarian Cohort n=18 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Hepatocellular Cohort n=5 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Carcinoid Cohort n=7 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Double Agent) Cohort n=23 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Bevacizumab-only) Cohort n=4 Participants Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Duration of Response	25.1 months Interval 0.0 to 35.5	6.4 months Interval 3.7 to 10.8	6.4 months Interval 0.0 to 11.1	15.0 months Interval 0.0 to 18.8	11.3 months Interval 8.8 to 21.2	10.9 months Interval 3.7 to 34.1

SECONDARY outcome

Timeframe: Every cycle of treatment, up to 3 years

Population: All patients that received protocol treatment and were evaluated for adverse events are reported in this analysis.

Adverse events are defined as events that are classified as either possibly, probably, or definitely related to study treatment, graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0. The number of patients reporting grade 3 or higher adverse events at least possibly related to treatment are reported here. For a complete list of all reported adverse events, please see the adverse events section of this report.

Outcome measures

Measure	Endometrial Cohort n=26 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Ovarian Cohort n=58 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Hepatocellular Cohort n=27 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Carcinoid Cohort n=57 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Double Agent) Cohort n=55 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Bevacizumab-only) Cohort n=24 Participants Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Incidence of Adverse Events Grade 3 Adverse Event	17 Participants	32 Participants	24 Participants	32 Participants	36 Participants	13 Participants
Incidence of Adverse Events Grade 4 Adverse Event	1 Participants	6 Participants	0 Participants	6 Participants	8 Participants	0 Participants
Incidence of Adverse Events Grade 5 Adverse Event	1 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Time from registration to death, assessed up to 3 years

Population: All patients that received study intervention and were followed for survival were included in this analysis.

Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method.

Outcome measures

Measure	Endometrial Cohort n=26 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Ovarian Cohort n=58 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Hepatocellular Cohort n=27 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Carcinoid Cohort n=57 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Double Agent) Cohort n=58 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Bevacizumab-only) Cohort n=24 Participants Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Survival	11.5 months Interval 6.5 to Too few deaths occurred to estimate an upper 95% CI.	16.3 months Interval 11.1 to 21.9	14.8 months Interval 9.7 to 18.1	32.7 months Interval 25.2 to 38.3	35.0 months Interval 14.6 to Too few deaths occurred to estimate an upper 95% CI.	NA months Interval 30.6 to Too few deaths occurred to estimate a median or an upper 95% CI.

SECONDARY outcome

Timeframe: Time from registration to disease progression, assessed up to 3 years

Population: All patients that began protocol treatment and were evaluated for response are included in this analysis.

Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for evaluation, that patient will be censored for progression of disease at day one post-registration.

Outcome measures

Measure	Endometrial Cohort n=26 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Ovarian Cohort n=58 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Hepatocellular Cohort n=27 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Carcinoid Cohort n=55 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Double Agent) Cohort n=54 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Bevacizumab-only) Cohort n=24 Participants Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Time to Disease Progression	6.0 months Interval 2.5 to 9.8	5.6 months Interval 4.3 to 6.4	8.0 months Interval 5.8 to 10.9	15.2 months Interval 11.4 to 24.2	13.1 months Interval 11.2 to 16.6	18.0 months Interval 10.6 to 37.0

SECONDARY outcome

Timeframe: Time from study entry to the date patients end treatment, assessed up to 3 years

Population: All patients that began study treatment were included in this analysis.

Time to treatment failure is defined as the time from study entry to the date patients end treatment.Time to treatment failure will be evaluated using the method of Kaplan-Meier.

Outcome measures

Measure	Endometrial Cohort n=26 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Ovarian Cohort n=58 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Hepatocellular Cohort n=27 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Carcinoid Cohort n=55 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Double Agent) Cohort n=54 Participants Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Bevacizumab-only) Cohort n=24 Participants Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Time to Treatment Failure	3.8 months Interval 2.3 to 6.4	4.5 months Interval 2.7 to 5.6	6.5 months Interval 2.3 to 8.0	5.5 months Interval 4.4 to 8.1	11.3 months Interval 8.6 to 13.3	11.8 months Interval 5.8 to 18.0

Adverse Events

Endometrial Cohort

Serious events: 16 serious events

Other events: 26 other events

Deaths: 2 deaths

Ovarian Cohort

Serious events: 34 serious events

Other events: 58 other events

Deaths: 1 deaths

Hepatocellular Cohort

Serious events: 13 serious events

Other events: 27 other events

Deaths: 3 deaths

Carcinoid Cohort

Serious events: 36 serious events

Other events: 56 other events

Deaths: 3 deaths

Islet Cell (Double Agent) Cohort

Serious events: 27 serious events

Other events: 55 other events

Deaths: 0 deaths

Islet Cell (Bevacizumab-only) Cohort

Serious events: 6 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Endometrial Cohort n=26 participants at risk Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Ovarian Cohort n=58 participants at risk Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Hepatocellular Cohort n=27 participants at risk Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Carcinoid Cohort n=57 participants at risk Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Double Agent) Cohort n=55 participants at risk Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Bevacizumab-only) Cohort n=24 participants at risk Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders Rectal pain	7.7% 2/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Small intestinal obstruction	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Fatigue	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	14.8% 4/27 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Fever	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Ill-defined disorder	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Multi-organ failure	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Pain	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Vomiting	7.7% 2/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	6.9% 4/58 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Chest pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Chills	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Disease progression	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Edema limbs	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Catheter related infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Pneumonia	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Sepsis	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Gallbladder infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Sudden death	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Visceral edema	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Hepatobiliary disorders Hepatic hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Abdominal infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Anal infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Anorectal infection	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Biliary tract infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Urinary tract infection	7.7% 2/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Wound infection	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Injury, poisoning and procedural complications Fracture	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Injury, poisoning and procedural complications Postoperative hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Skin infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Alkaline phosphatase increased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Aspartate aminotransferase increased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Bilirubin increased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Creatinine increased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations INR increased	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Laboratory test abnormal	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Injury, poisoning and procedural complications Rectal anastomotic leak	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Leukocyte count decreased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Lymphocyte count decreased	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Neutrophil count decreased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Platelet count decreased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Alanine aminotransferase increased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Serum cholesterol increased	7.7% 2/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Weight gain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Weight loss	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Anorexia	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Blood glucose increased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Dehydration	7.7% 2/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.8% 5/57 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum albumin decreased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum glucose decreased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum phosphate decreased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum potassium decreased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum potassium increased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum sodium decreased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Buttock pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Joint pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Cognitive disturbance	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Depressed level of consciousness	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Dizziness	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Headache	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Intracranial hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Pain in extremity	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Obstruction gastric	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Oral pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Rectal fistula	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Blood and lymphatic system disorders Hemoglobin decreased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Arrhythmia	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Atrial fibrillation	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Cardiac disorder	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Cardiac pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Left ventricular dysfunction	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Left ventricular failure	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Myocardial ischemia	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Palpitations	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Abdominal distension	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Abdominal pain	7.7% 2/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	11.1% 3/27 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	14.0% 8/57 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	10.9% 6/55 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Anal fistula	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Anal pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Anal ulcer	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Colitis	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Colonic obstruction	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Colonic perforation	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Constipation	3.8% 1/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Diarrhea	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Dry mouth	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Duodenal hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Duodenal perforation	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Dyspepsia	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Ear, nose and throat examination abnormal	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Esophageal hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Esophageal ulcer	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Esophagitis	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Gastritis	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Hemorrhoids	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Ileus	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Nausea	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	6.9% 4/58 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Ischemia cerebrovascular	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Leukoencephalopathy	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Memory impairment	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Neurological disorder NOS	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Syncope	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Psychiatric disorders Confusion	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	11.1% 3/27 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Psychiatric disorders Depression	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Psychiatric disorders Psychosis	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Protein urine positive	7.7% 2/26 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Renal failure	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Urinary incontinence	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Urogenital disorder	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Reproductive system and breast disorders Vaginal fistula	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.7% 2/26 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Rash desquamating	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Skin disorder	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Skin ulceration	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Vascular disorders Hypertension	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.3% 4/55 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Vascular disorders Hypotension	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Vascular disorders Thrombosis	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Vascular disorders Visceral arterial ischemia	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.

Other adverse events

Measure	Endometrial Cohort n=26 participants at risk Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Ovarian Cohort n=58 participants at risk Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Hepatocellular Cohort n=27 participants at risk Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Carcinoid Cohort n=57 participants at risk Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Double Agent) Cohort n=55 participants at risk Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Islet Cell (Bevacizumab-only) Cohort n=24 participants at risk Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.7% 2/26 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	11.5% 3/26 • Number of events 16 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	6.9% 4/58 • Number of events 11 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	10.5% 6/57 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	10.9% 6/55 • Number of events 14 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Blood and lymphatic system disorders Blood disorder	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Blood and lymphatic system disorders Hemoglobin decreased	76.9% 20/26 • Number of events 79 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	82.8% 48/58 • Number of events 212 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	85.2% 23/27 • Number of events 122 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	86.0% 49/57 • Number of events 382 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	89.1% 49/55 • Number of events 556 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	33.3% 8/24 • Number of events 82 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Blood and lymphatic system disorders Hemolysis	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 9 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Blood and lymphatic system disorders Lymphatic disorder	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Arrhythmia	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Atrial fibrillation	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 13 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Atrial tachycardia	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Atrioventricular block complete	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Cardiac disorder	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Cardiac pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Palpitations	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Cardiac disorders Pericardial effusion	3.8% 1/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Ear and labyrinth disorders External ear pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Ear and labyrinth disorders Hearing loss	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Ear and labyrinth disorders Hearing test abnormal	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Ear and labyrinth disorders Tinnitus	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Eye disorders Cataract	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Eye disorders Dry eye syndrome	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Eye disorders Eye disorder	3.8% 1/26 • Number of events 45 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Eye disorders Eye pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Eye disorders Flashing vision	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Eye disorders Retinal detachment	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Eye disorders Vision blurred	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Eye disorders Watering eyes	15.4% 4/26 • Number of events 13 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Abdominal distension	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 9 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Abdominal pain	7.7% 2/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	22.4% 13/58 • Number of events 21 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	14.8% 4/27 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	19.3% 11/57 • Number of events 27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.7% 7/55 • Number of events 19 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Anal fistula	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Anal hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Anal mucositis	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Anal pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	6.9% 4/58 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Anal ulcer	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Ascites	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Cheilitis	3.8% 1/26 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Constipation	26.9% 7/26 • Number of events 25 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	19.0% 11/58 • Number of events 16 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	11.1% 3/27 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.3% 7/57 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	16.4% 9/55 • Number of events 17 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.3% 2/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Diarrhea	34.6% 9/26 • Number of events 36 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	31.0% 18/58 • Number of events 39 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	25.9% 7/27 • Number of events 20 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	57.9% 33/57 • Number of events 113 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	38.2% 21/55 • Number of events 73 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	20.8% 5/24 • Number of events 20 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Dry mouth	15.4% 4/26 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	6.9% 4/58 • Number of events 28 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.8% 5/57 • Number of events 24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Dyspepsia	7.7% 2/26 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 12 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Dysphagia	7.7% 2/26 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 15 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Ear, nose and throat examination abnormal	46.2% 12/26 • Number of events 31 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	31.0% 18/58 • Number of events 44 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	14.8% 4/27 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	49.1% 28/57 • Number of events 76 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	60.0% 33/55 • Number of events 116 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.5% 3/24 • Number of events 23 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Esophageal mucositis	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Esophageal pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Fecal incontinence	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Flatulence	3.8% 1/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Gastric mucositis	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Gastritis	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Gastrointestinal disorder	3.8% 1/26 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.3% 7/57 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	9.1% 5/55 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.3% 2/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Gastroscopy abnormal	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Gingival pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 15 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Hemorrhoids	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	17.5% 10/57 • Number of events 15 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.3% 4/55 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Lip pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 9 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Mucositis oral	19.2% 5/26 • Number of events 13 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	46.6% 27/58 • Number of events 86 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	40.7% 11/27 • Number of events 27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	29.8% 17/57 • Number of events 25 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	21.8% 12/55 • Number of events 43 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.3% 2/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Nausea	42.3% 11/26 • Number of events 63 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	41.4% 24/58 • Number of events 49 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	33.3% 9/27 • Number of events 22 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	40.4% 23/57 • Number of events 63 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	40.0% 22/55 • Number of events 69 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	16.7% 4/24 • Number of events 13 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Oesophagoscopy abnormal	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Oral hemorrhage	3.8% 1/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Oral pain	19.2% 5/26 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.3% 7/57 • Number of events 17 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 13 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Periodontal disease	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Rectal fistula	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Rectal pain	3.8% 1/26 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	6.9% 4/58 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.8% 5/57 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Rectal ulcer	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Stomach pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Tooth disorder	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Toothache	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	11.5% 3/26 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	14.8% 4/27 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.8% 5/57 • Number of events 12 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	14.5% 8/55 • Number of events 21 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Gastrointestinal disorders Vomiting	26.9% 7/26 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	13.8% 8/58 • Number of events 13 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	18.5% 5/27 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	22.8% 13/57 • Number of events 24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	30.9% 17/55 • Number of events 26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.5% 3/24 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Chest pain	3.8% 1/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Chills	11.5% 3/26 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 12 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Edema limbs	19.2% 5/26 • Number of events 22 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	13.8% 8/58 • Number of events 25 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	11.1% 3/27 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	21.1% 12/57 • Number of events 55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	27.3% 15/55 • Number of events 70 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.3% 2/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Facial pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Fatigue	80.8% 21/26 • Number of events 120 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	74.1% 43/58 • Number of events 152 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	51.9% 14/27 • Number of events 67 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	70.2% 40/57 • Number of events 236 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	87.3% 48/55 • Number of events 293 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	50.0% 12/24 • Number of events 70 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Fever	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	6.9% 4/58 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	11.1% 3/27 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.8% 5/57 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.3% 4/55 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Flu-like symptoms	7.7% 2/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Gait abnormal	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders General symptom	7.7% 2/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 15 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Ill-defined disorder	3.8% 1/26 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Injection site reaction	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Localized edema	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
General disorders Pain	15.4% 4/26 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 31 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	20.0% 11/55 • Number of events 57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.3% 2/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Immune system disorders Hypersensitivity	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Immune system disorders Immune system disorder	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Bladder infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Bronchitis	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Eye infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Gingival infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Infection	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	14.8% 4/27 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.5% 3/24 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Joint infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Lip infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Nail infection	7.7% 2/26 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Pelvic infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Pneumonia	3.8% 1/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Sinusitis	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Skin infection	7.7% 2/26 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Soft tissue infection	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Tooth infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Upper respiratory infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Urinary tract infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Vaginal infection	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Infections and infestations Wound infection	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Injury, poisoning and procedural complications Bruising	3.8% 1/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 9 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 9 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.3% 4/55 • Number of events 18 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Injury, poisoning and procedural complications Fracture	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Injury, poisoning and procedural complications Tracheal hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Activated partial thromboplastin time prolonged	7.7% 2/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Alanine aminotransferase increased	34.6% 9/26 • Number of events 28 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	24.1% 14/58 • Number of events 24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	22.2% 6/27 • Number of events 33 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	31.6% 18/57 • Number of events 62 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	45.5% 25/55 • Number of events 113 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.5% 3/24 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Alkaline phosphatase increased	26.9% 7/26 • Number of events 33 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	22.4% 13/58 • Number of events 24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	11.1% 3/27 • Number of events 17 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	35.1% 20/57 • Number of events 114 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	34.5% 19/55 • Number of events 76 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.5% 3/24 • Number of events 22 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Aspartate aminotransferase increased	42.3% 11/26 • Number of events 40 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	34.5% 20/58 • Number of events 43 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	29.6% 8/27 • Number of events 47 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	42.1% 24/57 • Number of events 100 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	56.4% 31/55 • Number of events 120 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	16.7% 4/24 • Number of events 9 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Bilirubin increased	3.8% 1/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	33.3% 9/27 • Number of events 21 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	24.6% 14/57 • Number of events 48 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	25.5% 14/55 • Number of events 40 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Creatinine increased	15.4% 4/26 • Number of events 20 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	15.5% 9/58 • Number of events 29 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	31.6% 18/57 • Number of events 60 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	16.4% 9/55 • Number of events 42 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	16.7% 4/24 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Fibrinogen decreased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations INR increased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Laboratory test abnormal	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Leukocyte count decreased	38.5% 10/26 • Number of events 26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	51.7% 30/58 • Number of events 108 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	59.3% 16/27 • Number of events 91 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	66.7% 38/57 • Number of events 158 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	61.8% 34/55 • Number of events 289 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.5% 3/24 • Number of events 12 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Lipase increased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Lymphocyte count decreased	23.1% 6/26 • Number of events 14 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.1% 7/58 • Number of events 11 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	22.2% 6/27 • Number of events 21 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	28.1% 16/57 • Number of events 72 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	34.5% 19/55 • Number of events 99 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Neutrophil count decreased	38.5% 10/26 • Number of events 15 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	43.1% 25/58 • Number of events 55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	55.6% 15/27 • Number of events 54 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	36.8% 21/57 • Number of events 62 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	50.9% 28/55 • Number of events 130 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.5% 3/24 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Platelet count decreased	61.5% 16/26 • Number of events 53 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	46.6% 27/58 • Number of events 86 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	81.5% 22/27 • Number of events 159 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	87.7% 50/57 • Number of events 327 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	74.5% 41/55 • Number of events 479 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	29.2% 7/24 • Number of events 52 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Serum cholesterol increased	84.6% 22/26 • Number of events 147 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	65.5% 38/58 • Number of events 162 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	44.4% 12/27 • Number of events 49 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	66.7% 38/57 • Number of events 231 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	83.6% 46/55 • Number of events 408 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	29.2% 7/24 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Weight gain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Investigations Weight loss	30.8% 8/26 • Number of events 15 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	15.5% 9/58 • Number of events 29 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	22.2% 6/27 • Number of events 30 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	35.1% 20/57 • Number of events 73 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	21.8% 12/55 • Number of events 38 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.3% 2/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Anorexia	61.5% 16/26 • Number of events 39 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	39.7% 23/58 • Number of events 59 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	29.6% 8/27 • Number of events 28 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	47.4% 27/57 • Number of events 72 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	52.7% 29/55 • Number of events 70 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	20.8% 5/24 • Number of events 14 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Blood bicarbonate decreased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Blood glucose increased	38.5% 10/26 • Number of events 43 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	24.1% 14/58 • Number of events 24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	14.8% 4/27 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	52.6% 30/57 • Number of events 159 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	50.9% 28/55 • Number of events 138 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	45.8% 11/24 • Number of events 33 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Dehydration	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.7% 7/55 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum albumin decreased	11.5% 3/26 • Number of events 15 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	10.3% 6/58 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	11.1% 3/27 • Number of events 11 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	22.8% 13/57 • Number of events 37 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	23.6% 13/55 • Number of events 49 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.3% 2/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum calcium decreased	11.5% 3/26 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	17.5% 10/57 • Number of events 23 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	20.0% 11/55 • Number of events 61 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum calcium increased	7.7% 2/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	25.0% 6/24 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum glucose decreased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum magnesium decreased	3.8% 1/26 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	10.3% 6/58 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 9 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum phosphate decreased	7.7% 2/26 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	6.9% 4/58 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	11.1% 3/27 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	17.5% 10/57 • Number of events 25 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	18.2% 10/55 • Number of events 22 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum potassium decreased	26.9% 7/26 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	17.2% 10/58 • Number of events 15 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	43.9% 25/57 • Number of events 63 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	20.0% 11/55 • Number of events 25 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.5% 3/24 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum potassium increased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	20.8% 5/24 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum sodium decreased	7.7% 2/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	11.1% 3/27 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	10.5% 6/57 • Number of events 15 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	25.5% 14/55 • Number of events 42 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	20.8% 5/24 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum sodium increased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Metabolism and nutrition disorders Serum triglycerides increased	61.5% 16/26 • Number of events 115 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	43.1% 25/58 • Number of events 73 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	25.9% 7/27 • Number of events 18 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	50.9% 29/57 • Number of events 176 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	58.2% 32/55 • Number of events 172 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Back pain	19.2% 5/26 • Number of events 12 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	18.5% 5/27 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Buttock pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Chest wall pain	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Joint disorder	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Joint effusion	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Joint pain	19.2% 5/26 • Number of events 41 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 11 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	6.9% 4/58 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	10.5% 6/57 • Number of events 11 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	10.9% 6/55 • Number of events 16 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	16.7% 4/24 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 2/26 • Number of events 16 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	10.3% 6/58 • Number of events 9 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	14.5% 8/55 • Number of events 41 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Musculoskeletal and connective tissue disorders Pain in extremity	3.8% 1/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 18 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	10.9% 6/55 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.3% 2/24 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Depressed level of consciousness	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Dizziness	15.4% 4/26 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.1% 7/58 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	9.1% 5/55 • Number of events 13 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.3% 2/24 • Number of events 11 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Glossopharyngeal nerve disorder	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Headache	19.2% 5/26 • Number of events 39 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	39.7% 23/58 • Number of events 53 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	18.5% 5/27 • Number of events 11 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	35.1% 20/57 • Number of events 76 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	45.5% 25/55 • Number of events 117 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	25.0% 6/24 • Number of events 21 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Leukoencephalopathy	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Memory impairment	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Mini mental status examination abnormal	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Neurological disorder NOS	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 12 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Peripheral sensory neuropathy	11.5% 3/26 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	11.1% 3/27 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.3% 7/57 • Number of events 14 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Recurrent laryngeal nerve palsy	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Sinus pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Syncope	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Taste alteration	34.6% 9/26 • Number of events 39 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	20.7% 12/58 • Number of events 67 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	18.5% 5/27 • Number of events 22 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	21.1% 12/57 • Number of events 41 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	18.2% 10/55 • Number of events 70 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Nervous system disorders Tremor	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Psychiatric disorders Agitation	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Psychiatric disorders Anxiety	7.7% 2/26 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	6.9% 4/58 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.3% 2/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Psychiatric disorders Confusion	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Psychiatric disorders Depression	15.4% 4/26 • Number of events 11 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.1% 7/58 • Number of events 11 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.3% 4/55 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Psychiatric disorders Insomnia	23.1% 6/26 • Number of events 27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	6.9% 4/58 • Number of events 25 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	15.8% 9/57 • Number of events 31 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.7% 7/55 • Number of events 27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Bladder hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Bladder pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Bladder spasm	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Cystitis	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Glomerular filtration rate decreased	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Hemoglobin urine positive	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Hemorrhage urinary tract	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Kidney pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Protein urine positive	53.8% 14/26 • Number of events 111 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	51.7% 30/58 • Number of events 124 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	63.0% 17/27 • Number of events 67 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	61.4% 35/57 • Number of events 187 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	67.3% 37/55 • Number of events 341 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	50.0% 12/24 • Number of events 70 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Renal failure	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Urethral pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Urinary frequency	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 12 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	9.1% 5/55 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Urinary incontinence	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Renal and urinary disorders Urogenital disorder	7.7% 2/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Reproductive system and breast disorders Pelvic pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Reproductive system and breast disorders Perineal pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Reproductive system and breast disorders Vaginal fistula	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.4% 2/58 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Reproductive system and breast disorders Vaginal inflammation	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Reproductive system and breast disorders Vaginal mucositis	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Reproductive system and breast disorders Vaginal pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	11.5% 3/26 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 21 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Cough	23.1% 6/26 • Number of events 31 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	15.5% 9/58 • Number of events 25 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	11.1% 3/27 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	10.5% 6/57 • Number of events 14 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	14.5% 8/55 • Number of events 19 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.5% 3/24 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.4% 4/26 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	17.2% 10/58 • Number of events 18 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.3% 7/57 • Number of events 13 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	16.4% 9/55 • Number of events 12 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	26.9% 7/26 • Number of events 16 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	32.8% 19/58 • Number of events 76 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	18.5% 5/27 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	38.6% 22/57 • Number of events 84 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	38.2% 21/55 • Number of events 83 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Hiccough	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.8% 1/26 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	6.9% 4/58 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.8% 5/57 • Number of events 19 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.3% 4/55 • Number of events 28 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	7.7% 2/26 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.6% 2/55 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	11.5% 3/26 • Number of events 50 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 50 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.3% 2/24 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Respiratory tract hemorrhage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Tracheal mucositis	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Respiratory, thoracic and mediastinal disorders Voice alteration	11.5% 3/26 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 21 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 14 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	10.5% 6/57 • Number of events 14 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.3% 4/55 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Alopecia	15.4% 4/26 • Number of events 21 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	15.8% 9/57 • Number of events 28 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	16.4% 9/55 • Number of events 30 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.3% 2/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Dry skin	30.8% 8/26 • Number of events 53 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 10 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.3% 7/57 • Number of events 31 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	20.0% 11/55 • Number of events 29 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.6% 5/58 • Number of events 15 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.7% 7/55 • Number of events 23 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Nail disorder	26.9% 7/26 • Number of events 46 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.1% 7/58 • Number of events 42 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.8% 5/57 • Number of events 22 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.7% 7/55 • Number of events 89 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Pain of skin	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	11.1% 3/27 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	14.0% 8/57 • Number of events 9 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Photosensitivity	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 6 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Pruritus	30.8% 8/26 • Number of events 84 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	24.1% 14/58 • Number of events 38 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	14.8% 4/27 • Number of events 13 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	15.8% 9/57 • Number of events 22 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	23.6% 13/55 • Number of events 39 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Rash acneiform	34.6% 9/26 • Number of events 90 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	34.5% 20/58 • Number of events 86 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	18.5% 5/27 • Number of events 15 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	36.8% 21/57 • Number of events 86 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	29.1% 16/55 • Number of events 123 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Rash desquamating	34.6% 9/26 • Number of events 26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	25.9% 15/58 • Number of events 42 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	29.6% 8/27 • Number of events 27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	26.3% 15/57 • Number of events 70 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	45.5% 25/55 • Number of events 122 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Scalp pain	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Skin disorder	7.7% 2/26 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	12.1% 7/58 • Number of events 16 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	11.1% 3/27 • Number of events 4 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	10.5% 6/57 • Number of events 11 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	21.8% 12/55 • Number of events 42 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	3.8% 1/26 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Skin hypopigmentation	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 8 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Sweating	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.7% 1/27 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.0% 4/57 • Number of events 9 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Vascular disorders Flushing	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Vascular disorders Hematoma	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	3.5% 2/57 • Number of events 5 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Vascular disorders Hemorrhage	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.3% 3/57 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	9.1% 5/55 • Number of events 7 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	8.3% 2/24 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Vascular disorders Hot flashes	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 3 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/55 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	4.2% 1/24 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Vascular disorders Hypertension	61.5% 16/26 • Number of events 131 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	58.6% 34/58 • Number of events 174 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	37.0% 10/27 • Number of events 43 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	68.4% 39/57 • Number of events 186 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	63.6% 35/55 • Number of events 365 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	87.5% 21/24 • Number of events 145 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Vascular disorders Hypotension	3.8% 1/26 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/58 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Vascular disorders Lymph leakage	0.00% 0/26 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.7% 1/58 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/27 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/57 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/55 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.
Vascular disorders Thrombosis	11.5% 3/26 • Number of events 31 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.2% 3/58 • Number of events 13 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	7.4% 2/27 • Number of events 2 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	1.8% 1/57 • Number of events 1 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	5.5% 3/55 • Number of events 14 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.	0.00% 0/24 • Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles. Adverse events were collected at the end of each 28 day cycle for a maximum of 58 cycles.

Additional Information

Henry Pitot, M.D.

Mayo Clinic

Phone: (507) 284-2511

Email: pitot.henry@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60