Trial Outcomes & Findings for Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas (NCT NCT02357810)

Last Updated: 2022-06-07

Results Overview

PFS will be defined from the time of enrollment to the study until progression of disease or death from any cause, as assessed by RECIST 1.1 and measured at 12 weeks after treatment initiation for patients with STS. PFS estimates will be calculated using Kaplan-Meier methods Progression is defined as at least a 20% increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Progression must also involve an increase in size of measurable lesions by at least 5 mm, to minimize the possibility that small changes in a small number of target lesions is falsely interpreted as progression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

178 participants

Primary outcome timeframe

At 12 weeks from treatment initiation

Results posted on

2022-06-07

Participant Flow

The study opened to accrual February 25, 2015 and first patient initiated treatment March 20, 2015. The study was designed to enroll up to 105 patients with soft tissue sarcoma (for at least 92 evauable), up to 36 patients with osteosarcoma and 20 patients with liposarcoma for exploratory data. The study closed to further accrual June 10, 2020.

All patients reported here signed consent, completed eligibility requirements and were registered to the study.

Participant milestones

Participant milestones
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Registered and Started Treatment STARTED	178
Registered and Started Treatment Signed Consent	178
Registered and Started Treatment Registered to Study	152
Registered and Started Treatment Initiated Treatment on Study	151
Registered and Started Treatment COMPLETED	151
Registered and Started Treatment NOT COMPLETED	27
Reached 12 Weeks Response STARTED	151
Reached 12 Weeks Response Completed 4 Weeks/1 Cycle	151
Reached 12 Weeks Response Reached 6 Week Response	129
Reached 12 Weeks Response Reached 12 Weeks/3 Cycles	95
Reached 12 Weeks Response COMPLETED	95
Reached 12 Weeks Response NOT COMPLETED	56
12 Week Response and Further Treatment STARTED	95
12 Week Response and Further Treatment Assessed for 12 Week Response	95
12 Week Response and Further Treatment Went on to be Treated After Response	73
12 Week Response and Further Treatment COMPLETED	73
12 Week Response and Further Treatment NOT COMPLETED	22
Follow-up at Treatment Discontinuation STARTED	151
Follow-up at Treatment Discontinuation COMPLETED	144
Follow-up at Treatment Discontinuation NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Registered and Started Treatment Withdrawal by Subject	1
Registered and Started Treatment Found not to be eligible for the study	26
Reached 12 Weeks Response Adverse Event	5
Reached 12 Weeks Response Progressive Disease	39
Reached 12 Weeks Response Withdrawal by Subject	8
Reached 12 Weeks Response Protocol Violation	1
Reached 12 Weeks Response Death	1
Reached 12 Weeks Response Physician Decision	1
Reached 12 Weeks Response Other	1
12 Week Response and Further Treatment Adverse Event	5
12 Week Response and Further Treatment Withdrawal by Subject	1
12 Week Response and Further Treatment Progressive Disease	15
12 Week Response and Further Treatment Wound Complications	1
Follow-up at Treatment Discontinuation Withdrawal by Subject	4
Follow-up at Treatment Discontinuation Lost to Follow-up	3

Baseline Characteristics

Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) n=152 Participants Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	105 Participants n=5 Participants
Age, Categorical >=65 years	45 Participants n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	144 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants
Race (NIH/OMB) White	127 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	152 participants n=5 Participants
Histology Soft Tissue Sarcoma	105 participants n=5 Participants
Histology Liposarcoma	19 participants n=5 Participants
Histology Osteosarcoma	28 participants n=5 Participants

PRIMARY outcome

Timeframe: At 12 weeks from treatment initiation

Population: Only patients with soft tissue sarcoma were eligible for this endpoint. 105 patients enrolled in this trial had soft tissue sarcoma. 1 patient of these 105 was found not to be evaluable.

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) n=104 Participants Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Progression Free Survival at 12 Weeks for Patients With Soft Tissue Sarcoma (STS) Treated With Pazopanib and Oral Topotecan	57.5 percentage of patients progression free

SECONDARY outcome

Timeframe: During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33.

Population: Patients with Soft Tissue Sarcoma treated on study eligible for this endpoint, even if there are major protocol treatment deviations or patients exhibit objective disease progression prior to the end of cycle 1.

ORR is defined as the percentage of patients with Complete Response (CR) plus those with Partial Response (PR) as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Patients best response to treatment will be used in ORR. Complete Response - Disappearance of all target and non target lesions Partial Response - At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) n=104 Participants Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Overall Response Rate (ORR) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan.	7 Participants

SECONDARY outcome

Timeframe: During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33.

CBR is defined as the percentage of patients with Complete Response (CR) plus those with Partial Response (PR) plus those with Stable Disease (SD) as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Patients best response to treatment will be used in CBR where, in general the following definitions are used: Complete Response - Disappearance of all target and non target lesions Partial Response - At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started.

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) n=104 Participants Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Clinical Benefit Rate (CBR) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan.	66 Participants

SECONDARY outcome

Timeframe: During treatment where one cycle = 28 days and range of cycles completed by patients 1-33, then for 2 years (for patients with progression) and 5 years (for patients without progression) following discontinuation of treatment

Population: Only patients with soft tissue sarcoma were eligible for this endpoint. 105 patients enrolled in this trial had soft tissue sarcoma. 1 patient of these 105 was found not to be evaluable.

OS will be defined from start of study until death from any cause and estimates will be calculated using Kaplan-Meier methods. At time of Kaplan-meier calculations patients included the analysis who have not experienced the event will be censored at the last date of documentation of survival status.

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) n=104 Participants Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Overall Survival (OS) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan.	10.94 months Interval 9.3 to 18.73

SECONDARY outcome

Timeframe: From treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles

Toxicities will be tabulated and summarized by the number of patients experiencing each toxicity at grade 3 or grade 4

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) n=151 Participants Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Anemia	32 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Platelet count decreased	61 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Decreased neutrophil count	80 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Hypertension	35 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Fatigue	13 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Nausea	5 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Hyperglycemia	6 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Diarrhea	13 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Vomiting	11 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Anorexia	3 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Alkaline phosphatase increase	6 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Hyponatremia	17 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Hypocalcemia	1 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Aspartate aminotransferase increased	6 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Prolonged PTT	3 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 GGT increase	7 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Abdominal pain	7 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Hypokalemia	6 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Dyspnea	7 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 QTc prolongation	1 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 INR increased	2 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Alanine aminotransferase increase	8 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Blood bilirubin increased	2 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Epistaxis	2 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Creatinine increase	2 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Mucositis	1 patients
Number of Patients With Significant Adverse Events, Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 Proteinuria	6 patients

SECONDARY outcome

Timeframe: During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33. And then for up to 5 years post treatment discontinuation.

Population: Only patients with soft tissue sarcoma were eligible for this endpoint. 105 patients enrolled in this trial had soft tissue sarcoma. 1 patient of these 105 was found not to be evaluable.

PFS will be defined from the time of enrollment to the study until progression of disease or death from any cause, as assessed by RECIST 1.1. PFS estimates will be calculated using Kaplan-Meier methods. Patients included in the analysis, who did not experiences the event at the time of the calculation were censored from the last documentation of being progression free. Progression is defined as at least a 20% increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Progression must also involve an increase in size of measurable lesions by at least 5 mm, to minimize the possibility that small changes in a small number of target lesions is falsely interpreted as progression.

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) n=104 Participants Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Median Progression Free Survival (PFS) for Patients With Soft Tissue Sarcoma (STS) Treated With Combination Pazopanib and Topotecan.	4.37 months Interval 3.09 to 6.21

SECONDARY outcome

Timeframe: During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33. Then for up to 5 years post treatment discontinuation

Population: Only patients with Osteosarcoma were eligible for this endpoint.

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) n=28 Participants Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Progression Free Survival in Patients With Osteosarcoma Treated With Combination Pazopanib and Topotecan.	4.47 months Interval 2.76 to 8.28

SECONDARY outcome

Timeframe: During treatment, assessed at 6 weeks, 12 weeks, 20 weeks and then every 2 cycles where one cycle = 28 days and range of cycles completed by patients 1-33. Then up to 5 years post treatment discontinuation.

Population: Patients with liposarcoma were eligible for this endpoint.

PFS will be defined from the time of enrollment to the study until progression of disease or death from any cause, as assessed by RECIST 1.1. PFS estimates will be calculated using Kaplan-Meier methods. Patients who did not experiences the event at the time of the calculation were censored from the last documentation of being progression free. Progression is defined as at least a 20% increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Progression must also involve an increase in size of measurable lesions by at least 5 mm, to minimize the possibility that small changes in a small number of target lesions is falsely interpreted as progression.

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) n=19 Participants Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Progression Free Survival for Patients With Liposarcoma Treated With Combination Pazopanib and Topotecan.	1.48 Months Interval 1.25 to 12.85

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 weeks

Verification of results of Sleijfer et al and to determine if there is an even earlier correlation that can be detected between levels of these cytokines and PFR as well as OS which may allow us to better predict treatment response early on in therapy.

Outcome measures

Outcome data not reported

POST_HOC outcome

Timeframe: During treatment, where one cycle = 28 days and range of cycles completed by patients 1-33. Then for up to 5 years post treatment discontinuation.

Population: At the time of the calculation, 12 events were seen out of a possible 16.

OS is defined from enrollment to the study until death from any cause. OS estimates will be calculated using Kaplan-Meier methods. Patients included in the analysis who did not experience the event at the time of the calculation, were censored from the last documentation of being progression free.

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) n=16 Participants Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Overall Survival of Patients With Liposarcoma Treated With With Pazopanib and Oral Topotecan Combination	55.86 Weeks Interval 14.57 to 125.0

POST_HOC outcome

Timeframe: From time of initial response until progressive disease, up to 60 weeks.

Population: At time of analysis 66 events were seen out of the possible 68.

Duration of response is measured from the time of best response (Complete Response (CR), Partial Response (PR), Stable Disease SD)) as assessed by RECIST v1.1 until time of Progressive Disease (PD). Patients whose best response was PD are removed from this analysis. Patients who are included in the analysis but do not experience the event at the time of the calculation, will be censored at the last known date documented. CR-Disappearance of all target and non target lesions PR-≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD SD-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started PD- ≥20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) n=68 Participants Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Duration of Best Response in Patients With Soft Tissue Sarcoma Treated With Pazopanib and Topotecan Combination	25.71 Weeks Interval 20.0 to 33.29

POST_HOC outcome

Timeframe: From time of initial response until progressive disease, up to 60 weeks.

Population: At the time of the analysis 7 events were seen out of a possible 8.

Outcome measures

Outcome measures
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) n=8 Participants Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Duration of Best Response in Patients With Liposarcoma Treated With Pazopanib and Topotecan Combination	33.79 Weeks Interval 19.14 to 96.86

Adverse Events

Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride)

Serious events: 88 serious events

Other events: 151 other events

Deaths: 116 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) n=151 participants at risk；n=178 participants at risk Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Renal and urinary disorders Renal Calculi	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.8% 5/178 • Number of events 5 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Musculoskeletal and connective tissue disorders Generalized muscle weakness and malaise	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Abdominal pain	2.2% 4/178 • Number of events 4 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Upper respiratory infection	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Cardiac disorders Pericardial effusion	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Injury, poisoning and procedural complications Wound complications	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Urinary track infection with fever	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Increased alkaline phosphatase	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease progression	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Vascular disorders Superior Vena Cava Syndrome	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Acute Renal Failure	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Skin Infection	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Cardiac disorders Left Ventricular Systolic Dysfunction	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Vascular disorders Hypotension	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Thrombocytopenia	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders lower gastrointestinal hemorrhage	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Vascular disorders Stroke	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Eye disorders Blurred Vision	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Syncope	1.7% 3/178 • Number of events 3 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Hyperglycemia	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Pain	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders obstructed biliary stent	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Vascular disorders Thromboembolic Event	1.1% 2/178 • Number of events 2 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Blood and lymphatic system disorders Anemia	1.1% 2/178 • Number of events 2 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Blood and lymphatic system disorders Febrile neutropenia	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Fever	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Cardiac disorders Heart Failure	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Nausea and diarrhea	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Nausea and pain	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders vomiting	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations INR increase	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Colonic and bladder perforation	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Pain in extremity with anemia	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Back pain	1.1% 2/178 • Number of events 2 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Hypoxemia with dyspnea	0.56% 1/178 • Number of events 2 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Abdominal pain and distension	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Pelvic pain	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Reproductive system and breast disorders Vaginal hemorrhage	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Respiratory failure with dyspnea	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Nausea/vomiting/diarrhea	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Lung infection	1.1% 2/178 • Number of events 4 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Platelet Count Decrease	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Dehydration	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Sepsis with colonic perforation	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Hematuria	0.56% 1/178 • Number of events 2 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Edema in limbs	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Duodenal ulcer	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Abcess infection	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Acute Kidney Injury	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Urinary Track infection	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Diarrhea	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Back and abdominal pain	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Dysphagia	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Pancytopenia	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Abdominal Abscess/Enterocutaneous Fistula	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Elevated liver enzymes and bilirubin (Alkaline phosphatase, ALT, AST, GGT)	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Abdominal abscess and colitis	0.56% 1/178 • Number of events 1 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.

Other adverse events

Other adverse events
Measure	Treatment (Pazopanib Hydrochloride, Topotecan Hydrochloride) n=151 participants at risk；n=178 participants at risk Patients receive pazopanib hydrochloride PO QD on days 1-28 and topotecan hydrochloride PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Pazopanib Hydrochloride: Given PO Oral Topotecan Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies
Blood and lymphatic system disorders Anemia	74.2% 112/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	3.3% 5/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Blood and lymphatic system disorders Disseminated intravascular coagulation	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Blood and lymphatic system disorders Febrile neutropenia	4.0% 6/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Blood and lymphatic system disorders Leukocytosis	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Cardiac disorders Aortic valve disease	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Cardiac disorders Atrial fibrillation	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Cardiac disorders Atrioventricular block first degree	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Cardiac disorders Cardiac disorders - Other, specify	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Cardiac disorders Chest pain - cardiac	4.0% 6/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Cardiac disorders Heart failure	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Cardiac disorders Left ventricular systolic dysfunction	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Cardiac disorders Palpitations	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Cardiac disorders Pericardial effusion	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Cardiac disorders Sinus bradycardia	10.6% 16/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Cardiac disorders Sinus tachycardia	13.2% 20/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Ear and labyrinth disorders Disease progression	2.6% 4/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Ear and labyrinth disorders Ear pain	3.3% 5/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Ear and labyrinth disorders Hearing impaired	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Ear and labyrinth disorders Middle ear inflammation	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Ear and labyrinth disorders Tinnitus	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Ear and labyrinth disorders Vertigo	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Endocrine disorders Hyperthyroidism	5.3% 8/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Endocrine disorders Hypothyroidism	15.2% 23/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Eye disorders Blurred vision	3.3% 5/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Eye disorders Dry eye	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Eye disorders Platelet Count Decrease	4.6% 7/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Eye disorders Flashing lights	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Eye disorders Floaters	3.3% 5/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Eye disorders Photophobia	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Eye disorders Syncope	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Eye disorders Watering eyes	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Abdominal distension	5.3% 8/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Abdominal pain	29.1% 44/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Bloating	2.6% 4/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Colonic fistula	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Colonic hemorrhage	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Heart Failure	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Colonic perforation	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Constipation	19.2% 29/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Dental caries	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Diarrhea	57.6% 87/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Dry mouth	2.6% 4/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Duodenal ulcer	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Dyspepsia	8.6% 13/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Dysphagia	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Enterocolitis	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Flatulence	6.0% 9/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Gastroesophageal reflux disease	4.0% 6/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	9.3% 14/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Gastrointestinal pain	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Gastroparesis	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Hemorrhoidal hemorrhage	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Hemorrhoids	2.6% 4/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Mucositis oral	13.2% 20/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Nausea	70.2% 106/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Oral dysesthesia	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Oral hemorrhage	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Oral pain	7.3% 11/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Pancreatitis	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Rectal hemorrhage	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Stomach pain	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Toothache	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Gastrointestinal disorders Vomiting	56.3% 85/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Chills	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Death NOS	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Edema face	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Edema limbs	14.6% 22/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Edema trunk	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Skin Infection	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Fatigue	64.2% 97/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Fever	11.9% 18/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Flu like symptoms	4.0% 6/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders General disorders and administration site conditions - Other, specify	17.2% 26/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Irritability	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Localized edema	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Malaise	4.6% 7/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Non-cardiac chest pain	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
General disorders Pain	21.2% 32/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Immune system disorders Allergic reaction	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Anorectal infection	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Bronchial infection	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Enterocolitis infectious	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Eye infection	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Infections and infestations - Other, specify	2.6% 4/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Lip infection	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Lung infection	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Papulopustular rash	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Sepsis	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Sinusitis	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Skin infection	3.3% 5/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Upper respiratory infection	3.3% 5/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Infections and infestations Urinary tract infection	9.9% 15/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Injury, poisoning and procedural complications Bruising	3.3% 5/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Injury, poisoning and procedural complications Fall	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Injury, poisoning and procedural complications Fracture	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Injury, poisoning and procedural complications Intraoperative endocrine injury	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Injury, poisoning and procedural complications Urostomy obstruction	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Injury, poisoning and procedural complications Wound complication	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Activated partial thromboplastin time prolonged	29.1% 44/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Alanine aminotransferase increased	21.2% 32/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Alkaline phosphatase increased	31.8% 48/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Aspartate aminotransferase increased	37.1% 56/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Blood bilirubin increased	23.2% 35/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Cardiac troponin I increased	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Creatinine increased	10.6% 16/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Ejection fraction decreased	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Electrocardiogram QT corrected interval prolonged	15.2% 23/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations GGT increased	22.5% 34/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations INR increased	17.2% 26/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Investigations - Other, specify	4.6% 7/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Lymphocyte count decreased	57.0% 86/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Lymphocyte count increased	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Neutrophil count decreased	76.8% 116/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Pancreatic enzymes decreased	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Platelet count decreased	86.1% 130/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Weight gain	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations Weight loss	18.5% 28/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Investigations White blood cell decreased	82.1% 124/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Anorexia	46.4% 70/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Dehydration	9.3% 14/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Hypercalcemia	4.6% 7/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Hyperglycemia	51.7% 78/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Hyperkalemia	5.3% 8/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Hypermagnesemia	3.3% 5/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Hypernatremia	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Hyperuricemia	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Hypoalbuminemia	51.7% 78/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Hypocalcemia	42.4% 64/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Hypoglycemia	7.3% 11/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Hypokalemia	30.5% 46/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Hypomagnesemia	27.2% 41/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Hyponatremia	37.1% 56/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Hypophosphatemia	2.6% 4/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	6.0% 9/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 8/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Musculoskeletal and connective tissue disorders Back pain	19.2% 29/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Musculoskeletal and connective tissue disorders Bone pain	3.3% 5/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Musculoskeletal and connective tissue disorders Chest wall pain	4.0% 6/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Musculoskeletal and connective tissue disorders Flank pain	2.6% 4/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	3.3% 5/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	7.3% 11/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Musculoskeletal and connective tissue disorders Myalgia	13.2% 20/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Musculoskeletal and connective tissue disorders Neck pain	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Musculoskeletal and connective tissue disorders Pain in extremity	11.9% 18/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Musculoskeletal and connective tissue disorders Trismus	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	3.3% 5/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Dizziness	13.9% 21/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Dysarthria	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Dysgeusia	20.5% 31/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Encephalopathy	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Headache	28.5% 43/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Lethargy	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Nervous system disorders - Other, specify	2.6% 4/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Neuralgia	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Paresthesia	4.0% 6/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Peripheral motor neuropathy	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Peripheral sensory neuropathy	2.6% 4/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Sinus pain	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Stroke	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Nervous system disorders Syncope	4.0% 6/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Psychiatric disorders Agitation	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Psychiatric disorders Anxiety	4.0% 6/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Psychiatric disorders Confusion	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Psychiatric disorders Depression	5.3% 8/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Psychiatric disorders Insomnia	9.9% 15/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Bladder perforation	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Bladder spasm	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Chronic kidney disease	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Hematuria	9.9% 15/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Proteinuria	9.3% 14/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Renal and urinary disorders - Other, specify	6.6% 10/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Renal calculi	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Urinary frequency	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Urinary incontinence	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Urinary retention	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Urinary tract obstruction	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Urinary tract pain	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Renal and urinary disorders Urinary urgency	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Reproductive system and breast disorders Pelvic pain	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Reproductive system and breast disorders Vaginal discharge	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Reproductive system and breast disorders Vaginal dryness	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Reproductive system and breast disorders Vaginal hemorrhage	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Reproductive system and breast disorders Vaginal pain	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	3.3% 5/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Cough	17.2% 26/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.8% 39/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Epistaxis	17.9% 27/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Hiccups	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Hoarseness	6.0% 9/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.6% 7/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.6% 4/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.3% 8/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Pleural hemorrhage	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Pneumothorax	4.0% 6/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Postnasal drip	3.3% 5/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Productive cough	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	4.0% 6/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Sore throat	5.3% 8/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Respiratory, thoracic and mediastinal disorders Wheezing	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Skin and subcutaneous tissue disorders Alopecia	7.9% 12/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Skin and subcutaneous tissue disorders Dry skin	4.0% 6/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Skin and subcutaneous tissue disorders Erythema multiforme	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	10.6% 16/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Skin and subcutaneous tissue disorders Pruritus	2.6% 4/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Skin and subcutaneous tissue disorders Purpura	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Skin and subcutaneous tissue disorders Rash acneiform	2.6% 4/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.0% 6/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	9.3% 14/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Skin and subcutaneous tissue disorders Skin hypopigmentation	4.6% 7/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Skin and subcutaneous tissue disorders Skin ulceration	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Surgical and medical procedures Surgical and medical procedures - Other, specify	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Vascular disorders Flushing	1.3% 2/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Vascular disorders Hot flashes	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Vascular disorders Hypertension	62.9% 95/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Vascular disorders Hypotension	5.3% 8/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Vascular disorders Lymphedema	2.0% 3/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Vascular disorders Superficial thrombophlebitis	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Vascular disorders Superior vena cava syndrome	0.66% 1/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.
Vascular disorders Thromboembolic event	4.0% 6/151 • Adverse Events (AE) data was collected for each patient from treatment initiation until 30 days post last treatment, at the beginning of each cycle where 1 cycle=28 days. Range of cycles completed by patients 1-33 cycles. Serious Adverse Event (SAE) data is collected from the time of consent (regardless of if a patient initiates treatment) until 30 days post last treatment. All cause mortality was collected for patients who initiated treatment, and up to 5 years post treatment discontinuation. Data entry is currently being completed for the most recent patients - this Section will be updated with final adverse event data at the end of the study. Due to data collection methods some SAE data may also be included in Other AE as well as in Serious Adverse Event Section. Patients who signed consent/did not initiate treatment are included as at risk for SAE but not at risk for other AEs due to 5 out of 26 screenfail patients experiencing an SAE.

Additional Information

Mary Mulcahy, MD

Northwestern University

Phone: 312-695-0990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place