Trial Outcomes & Findings for Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer (NCT NCT00625846)

Last Updated: 2020-02-26

Results Overview

The tumor response rate is defined as the percentage of eligible patients who fulfill RECIST 1.0 for a complete or partial response at two consecutive assessments at least 8 weeks apart for patients in Cohorts 1-3. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

152 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2020-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 (DTC) Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Cohort 2 (MTC) Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Cohort 3 (ATC) Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Expansion Cohort (DTC) Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	39	35	16	62
Overall Study COMPLETED	37	35	15	60
Overall Study NOT COMPLETED	2	0	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 (DTC) Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Cohort 2 (MTC) Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Cohort 3 (ATC) Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Expansion Cohort (DTC) Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study Withdrawal by Subject	2	0	1	2

Baseline Characteristics

Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 (DTC) n=37 Participants Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Cohort 2 (MTC) n=35 Participants Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Cohort 3 (ATC) n=15 Participants Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Expansion Cohort (DTC) n=60 Participants Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Total n=147 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	60 years n=7 Participants	66 years n=5 Participants	60 years n=4 Participants	61 years n=21 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	27 Participants n=4 Participants	62 Participants n=21 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	28 Participants n=7 Participants	5 Participants n=5 Participants	33 Participants n=4 Participants	85 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	33 Participants n=7 Participants	12 Participants n=5 Participants	57 Participants n=4 Participants	131 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	10 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	17 Participants n=4 Participants	28 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	28 Participants n=7 Participants	12 Participants n=5 Participants	37 Participants n=4 Participants	112 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment Singapore	1 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	3 participants n=4 Participants	9 participants n=21 Participants
Region of Enrollment United States	35 participants n=5 Participants	26 participants n=7 Participants	13 participants n=5 Participants	38 participants n=4 Participants	112 participants n=21 Participants
Region of Enrollment China	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Region of Enrollment Taiwan	0 participants n=5 Participants	3 participants n=7 Participants	0 participants n=5 Participants	10 participants n=4 Participants	13 participants n=21 Participants
Region of Enrollment Australia	1 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	9 participants n=4 Participants	12 participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: All patients in Cohort 1, Cohort 2, and Cohort 3 that received treatment and were eligible for response assessment were included in this analysis.

Outcome measures

Outcome measures
Measure	Cohort 1 (DTC) n=37 Participants Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pazopanib Hydrochloride: Given PO	Cohort 2 (MTC) n=35 Participants Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Pazopanib Hydrochloride: Given PO	Cohort 3 (ATC) n=15 Participants Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies	Expansion Cohort (DTC) Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pazopanib Hydrochloride: Given PO
Overall Response Rate (in Cohorts 1-3)	49 percentage of participants Interval 35.0 to 68.0	14 percentage of participants Interval 6.0 to 28.0	0 percentage of participants Interval 0.0 to 22.0	—

PRIMARY outcome

Timeframe: Up to 3 years

Population: All patients that registered to the Differential Thyroid Expansion cohort and were evaluable for response assessment were included in this analysis.

The confirmed tumor response rate is defined as the percentage of eligible patients who fulfill RECIST 1.0 for a complete or partial response at two consecutive assessments at least 8 weeks apart for patients with differentiated thyroid cancer who are thyroglobulin antibody negative. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Cohort 1 (DTC) Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pazopanib Hydrochloride: Given PO	Cohort 2 (MTC) Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Pazopanib Hydrochloride: Given PO	Cohort 3 (ATC) Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies	Expansion Cohort (DTC) n=60 Participants Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pazopanib Hydrochloride: Given PO
Confirmed Tumor Response (in the Differentiated Thyroid Cancer Expansion Cohort)	—	—	—	37 percentage of participants Interval 25.0 to 50.0

SECONDARY outcome

Timeframe: Up to 3 years

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

Toxicity (defined as grade 3+ adverse events deemed possibly, probably, or definitely related to treatment) will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. The percentage of patients with grade 3+ adverse events deemed possibly, probably, or definitely related to treatment are reported for patients in Cohorts 1-3.

Outcome measures

Outcome measures
Measure	Cohort 1 (DTC) n=38 Participants Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pazopanib Hydrochloride: Given PO	Cohort 2 (MTC) n=35 Participants Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Pazopanib Hydrochloride: Given PO	Cohort 3 (ATC) n=15 Participants Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies	Expansion Cohort (DTC) n=61 Participants Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pazopanib Hydrochloride: Given PO
Toxicity as Measured by the Percentage of Patients Reporting a Grade 3+ Adverse Event Deemed Possibly, Probably, or Definitely Related to Treatment	40 percentage of participants	46 percentage of participants	53 percentage of participants	53 percentage of participants

SECONDARY outcome

Timeframe: Time from registration to the date of progression or last follow-up, whichever comes first, assessed up to 6 months

Population: All patients in Cohort 1 and Cohort 2 that received treatment and were eligible for response assessment were included in this analysis.

Progression free survival at 6 months (PFS6) is defined as the proportion of patients alive and without progression at 6 months. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.

Outcome measures

Outcome measures
Measure	Cohort 1 (DTC) n=37 Participants Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pazopanib Hydrochloride: Given PO	Cohort 2 (MTC) n=35 Participants Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Pazopanib Hydrochloride: Given PO	Cohort 3 (ATC) Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies	Expansion Cohort (DTC) Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pazopanib Hydrochloride: Given PO
Progression-Free Survival at 6 Months (Cohorts 1 and 2 Only)	.71 proportion of participants Interval 0.58 to 0.87	.686 proportion of participants Interval 0.548 to 0.858	—	—

SECONDARY outcome

Timeframe: Time from registration to the date of progression or last follow-up, whichever comes first, assessed up to 3 months

Population: All patients from Cohort 3 that were treated and evaluable for response were included in this analysis.

Progression free survival at 3 months (PFS6) is defined as the proportion of patients alive and without progression at 3 months. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.

Outcome measures

Outcome measures
Measure	Cohort 1 (DTC) Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pazopanib Hydrochloride: Given PO	Cohort 2 (MTC) Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Pazopanib Hydrochloride: Given PO	Cohort 3 (ATC) n=15 Participants Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies	Expansion Cohort (DTC) Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pazopanib Hydrochloride: Given PO
Progression-Free Survival at 3 Months (Cohort 3 Only)	—	—	.267 proportion of participants Interval 0.115 to 0.617	—

Adverse Events

Cohort 1 (DTC)

Serious events: 21 serious events

Other events: 38 other events

Deaths: 3 deaths

Cohort 2 (MTC)

Serious events: 18 serious events

Other events: 35 other events

Deaths: 0 deaths

Cohort 3 (ATC)

Serious events: 9 serious events

Other events: 15 other events

Deaths: 1 deaths

Expansion Cohort (DTC)

Serious events: 31 serious events

Other events: 59 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Keith C. Bible, M.D., Ph.D.

Mayo Clinic

Phone: 507-284-2511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Cohort 1 (DTC) n=38 participants at risk Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Cohort 2 (MTC) n=35 participants at risk Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Cohort 3 (ATC) n=15 participants at risk Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Expansion Cohort (DTC) n=61 participants at risk Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nervous system disorders Speech disorder	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Nervous system disorders Taste alteration	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	6.6% 4/61 • Number of events 4 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Psychiatric disorders Agitation	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Nervous system disorders Peripheral sensory neuropathy	2.6% 1/38 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Blood and lymphatic system disorders Hemoglobin decreased	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Cardiac disorders Atrial fibrillation	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	6.7% 1/15 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Cardiac disorders Myocardial ischemia	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Cardiac disorders Sinus tachycardia	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Endocrine disorders Adrenal insufficiency	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Abdominal distension	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Abdominal pain	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	5.7% 2/35 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Colonic fistula	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Colonic perforation	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Constipation	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	6.7% 1/15 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Diarrhea	5.3% 2/38 • Number of events 20 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	3.3% 2/61 • Number of events 3 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Dry mouth	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Dysphagia	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Intra-abdominal hemorrhage	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Mucositis oral	5.3% 2/38 • Number of events 5 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	6.6% 4/61 • Number of events 6 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Mucositis oral (clin exam)	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Nausea	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Oral pain	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Small intestinal perforation	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Vomiting	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
General disorders Chest pain	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	3.3% 2/61 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
General disorders Death	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
General disorders Disease progression	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
General disorders Edema limbs	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
General disorders Fatigue	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	3.3% 2/61 • Number of events 3 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Infections and infestations Infection(gr 0/1/2 ANC)	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Infections and infestations Infectious colitis(gr 0/1/2 ANC)	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Infections and infestations Opportunistic infection	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Infections and infestations Peritoneal infection(gr 0/1/2 ANC)	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Infections and infestations Pneumonia(gr 0/1/2 ANC)	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Infections and infestations Pneumonia(gr 3/4 ANC)	5.3% 2/38 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Infections and infestations Wound infection(gr 0/1/2 ANC)	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Injury, poisoning and procedural complications Bruising	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Investigations Alanine aminotransferase increased	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Investigations Aspartate aminotransferase increased	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	6.7% 1/15 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.

Other adverse events
Measure	Cohort 1 (DTC) n=38 participants at risk Patients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Cohort 2 (MTC) n=35 participants at risk Patients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Cohort 3 (ATC) n=15 participants at risk Patients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Expansion Cohort (DTC) n=61 participants at risk Patients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Blood glucose increased	13.2% 5/38 • Number of events 18 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	8.6% 3/35 • Number of events 8 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Metabolism and nutrition disorders Blood uric acid increased	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Small intestinal mucositis	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Blood and lymphatic system disorders Hemoglobin decreased	44.7% 17/38 • Number of events 70 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	40.0% 14/35 • Number of events 103 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	46.7% 7/15 • Number of events 11 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	54.1% 33/61 • Number of events 182 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Cardiac disorders Palpitations	2.6% 1/38 • Number of events 5 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Ear and labyrinth disorders Tinnitus	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 13 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Eye disorders Conjunctival disorder	2.6% 1/38 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Eye disorders Diplopia	2.6% 1/38 • Number of events 5 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Eye disorders Flashing vision	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Eye disorders Photophobia	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Eye disorders Retinal detachment	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Eye disorders Vision blurred	5.3% 2/38 • Number of events 3 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Eye disorders Watering eyes	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Abdominal distension	5.3% 2/38 • Number of events 4 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Abdominal pain	7.9% 3/38 • Number of events 3 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	5.7% 2/35 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	6.6% 4/61 • Number of events 12 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Constipation	7.9% 3/38 • Number of events 6 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Diarrhea	73.7% 28/38 • Number of events 294 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	82.9% 29/35 • Number of events 380 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	46.7% 7/15 • Number of events 17 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	78.7% 48/61 • Number of events 505 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Dry mouth	5.3% 2/38 • Number of events 8 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	3.3% 2/61 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Dyspepsia	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Dysphagia	5.3% 2/38 • Number of events 4 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Flatulence	5.3% 2/38 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 5 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Mucositis oral	5.3% 2/38 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 6 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Mucositis oral (clin exam)	2.6% 1/38 • Number of events 3 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Nausea	76.3% 29/38 • Number of events 166 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	54.3% 19/35 • Number of events 94 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	40.0% 6/15 • Number of events 11 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	45.9% 28/61 • Number of events 136 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Oral hemorrhage	5.3% 2/38 • Number of events 3 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Oral pain	7.9% 3/38 • Number of events 4 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 6 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	2.6% 1/38 • Number of events 3 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	4.9% 3/61 • Number of events 4 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Gastrointestinal disorders Vomiting	47.4% 18/38 • Number of events 41 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	25.7% 9/35 • Number of events 31 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	20.0% 3/15 • Number of events 3 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	32.8% 20/61 • Number of events 71 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
General disorders Chest pain	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
General disorders Chills	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
General disorders Edema limbs	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
General disorders Fatigue	92.1% 35/38 • Number of events 275 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	82.9% 29/35 • Number of events 286 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	80.0% 12/15 • Number of events 28 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	82.0% 50/61 • Number of events 479 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
General disorders Fever	7.9% 3/38 • Number of events 3 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	3.3% 2/61 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
General disorders Flu-like symptoms	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	2.9% 1/35 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
General disorders Localized edema	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
General disorders Pain	7.9% 3/38 • Number of events 3 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	4.9% 3/61 • Number of events 3 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Infections and infestations Eye infection	0.00% 0/38 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 2 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Infections and infestations Infection(gr 0/1/2 ANC)	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	1.6% 1/61 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.
Infections and infestations Soft tissue infection	2.6% 1/38 • Number of events 1 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/35 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/15 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.	0.00% 0/61 • Adverse events were collected at the end of every 28 day cycle, up to 84 cycles. Adverse events were collected at the end of every 28 day cycle, up to 84 cycles.