Trial Outcomes & Findings for Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma (NCT NCT03534804)

NCT ID: NCT03534804

Last Updated: 2024-11-26

Results Overview

To evaluate measurable disease overall response. Subjects were evaluated by CT scans at regular intervals for disease assessment by RECISTv1.1 criteria for the duration of treatment. Response Evaluation Criteria in Solid Tumors (RECIST) is a standard measure of how well cancer patients respond to treatment. Possible scores are CR (Complete Response; total disappearance of all target lesions), PR (Partial Response; at least a 30% decrease of the sum of the longest diameter of all target lesions), PD (Progressive Disease; at least a 20% increase of the sum of the longest diameter of all target lesions), and SD (Stable Disease; neither a sufficient decrease for PR, or sufficient increase for PD). Overall response is the count of PR and CR scores among the participants' best RECISTv1.1 responses.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 37 participants
• Primary outcome timeframe: From baseline disease assessment to best response disease assessment, measured up to 28 months.
• Results posted on: 2024-11-26

Participant Flow

36 participants received study treatment. Adverse event collection started at consent, hence there is additional one participant who experienced an SAE during screening and did not enroll in the study.

Participant milestones

Measure	Cabozantinib and Pembrolizumab, All Patients Cabozantinib: Cabozantinib was administered at 40 mg oral daily. Pembrolizumab: Pembrolizumab was administered at a fixed dose of 200mg intravenously every 3 weeks.
Overall Study STARTED	36
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Cabozantinib and Pembrolizumab, All Patients Cabozantinib: Cabozantinib was administered at 40 mg oral daily. Pembrolizumab: Pembrolizumab was administered at a fixed dose of 200mg intravenously every 3 weeks.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma

Baseline characteristics by cohort

Measure	Cabozantinib and Pembrolizumab, All Patients n=36 Participants Cabozantinib: Cabozantinib was administered at 40 mg oral daily. Pembrolizumab: Pembrolizumab was administered at a fixed dose of 200mg intravenously every 3 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	30 Participants n=5 Participants
Age, Continuous	70.06 years STANDARD_DEVIATION 7.78 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants
ECOG at Baseline Fully Active	11 Participants n=5 Participants
ECOG at Baseline Restricted	21 Participants n=5 Participants
ECOG at Baseline Ambulatory	4 Participants n=5 Participants
ECOG at Baseline Capable of limited selfcare	0 Participants n=5 Participants
ECOG at Baseline Completely disabled	0 Participants n=5 Participants
ECOG at Baseline Dead	0 Participants n=5 Participants
ECOG at Baseline Not Done	0 Participants n=5 Participants
Overall Stage at Enrollment I: cancer has not spread to the muscle (Tis+N0+M0).	1 Participants n=5 Participants
Overall Stage at Enrollment III: cancer has spread through the bladder to nearby tissues (T3+N0+M0)	1 Participants n=5 Participants
Overall Stage at Enrollment IIIA: cancer has spread to the fat surrounding the bladder (T3a/T3b/T4a+N0+M0) or (T1-4a, N1+M0).	1 Participants n=5 Participants
Overall Stage at Enrollment IV: cancer spread to far lymph nodes or organs (T4+NX/N0+M0), (Any T+N1/N2+M0), or (Any T+Any N+M1).	27 Participants n=5 Participants
Overall Stage at Enrollment IVA: cancer spread to the pelvic or abdominal wall (T4b + Any N + M0) or (Any T + Any N + M1a).	1 Participants n=5 Participants
Overall Stage at Enrollment IVB: cancer spread to distant organs (Any T + Any N + M1b)	2 Participants n=5 Participants
Overall Stage at Enrollment Unknown/Unable to Determine	3 Participants n=5 Participants
Primary Location of Disease Lower Tract	17 Participants n=5 Participants
Primary Location of Disease Upper Tract	18 Participants n=5 Participants
Primary Location of Disease Upper and Lower Tract	1 Participants n=5 Participants
Height	173.66 cm STANDARD_DEVIATION 9.84 • n=5 Participants
Weight	90.36 kg STANDARD_DEVIATION 26.74 • n=5 Participants
BMI	29.71 kg/m^2 STANDARD_DEVIATION 7.44 • n=5 Participants
Smoking Status Current Smoker	4 Participants n=5 Participants
Smoking Status Former Smoker	19 Participants n=5 Participants
Smoking Status Non-Smoker	13 Participants n=5 Participants
History of Hypertension No	7 Participants n=5 Participants
History of Hypertension Yes	29 Participants n=5 Participants
T Stage at Enrollment T0: There is no evidence of a primary tumor.	3 Participants n=5 Participants
T Stage at Enrollment T1: The cancer has grown into the connective tissue of the bladder but not the muscle layer.	8 Participants n=5 Participants
T Stage at Enrollment T1a: A subset of T1 in which the tumor has not grown into the muscular mucosae-vascular plexus.	1 Participants n=5 Participants
T Stage at Enrollment T2: The cancer has grown into the bladder's muscle layer, but it has not reached fatty tissue layer.	6 Participants n=5 Participants
T Stage at Enrollment T3: The cancer grew into the bladder's fatty tissue layer but not into the pelvic or abdominal wall.	5 Participants n=5 Participants
T Stage at Enrollment T4: The cancer has grown through the bladder into the pelvic or abdominal wall.	4 Participants n=5 Participants
T Stage at Enrollment Tx: Insufficient information to assess the tumor.	8 Participants n=5 Participants
T Stage at Enrollment Unknown/Unable to Determine	1 Participants n=5 Participants
N Stage at Enrollment N0: The cancer did not spread to lymph nodes.	13 Participants n=5 Participants
N Stage at Enrollment N1: The cancer spread to 1 lymph node in the pelvis.	5 Participants n=5 Participants
N Stage at Enrollment N2: The cancer spread to 2 or more lymph nodes in the pelvis.	5 Participants n=5 Participants
N Stage at Enrollment N3: The cancer spread to lymph nodes farther away from the bladder (along the common iliac arteries)	4 Participants n=5 Participants
N Stage at Enrollment NX: Due to lack of information, regional lymph nodes could not be assessed.	7 Participants n=5 Participants
N Stage at Enrollment Unknown/Unable to Determine	2 Participants n=5 Participants
M Stage at Enrollment M0: The cancer has not spread to other parts of the body.	4 Participants n=5 Participants
M Stage at Enrollment M1: The cancer has spread to other parts of the body.	21 Participants n=5 Participants
M Stage at Enrollment M1a: The cancer has spread to distant lymph nodes.	2 Participants n=5 Participants
M Stage at Enrollment M1b: The cancer has spread to 1 or more distant organs.	3 Participants n=5 Participants
M Stage at Enrollment MX: Due to a lack of information, metastasis could not be assessed.	3 Participants n=5 Participants
M Stage at Enrollment Unknown/Unable to Determine	3 Participants n=5 Participants
Histology Mixed	8 Participants n=5 Participants
Histology Pure Urothelial	28 Participants n=5 Participants
Prior Chemotherapy Yes	10 Participants n=5 Participants
Prior Chemotherapy No	26 Participants n=5 Participants
Prior Bacillus Calmette-Guerin (BCG) Treatment Yes	10 Participants n=5 Participants
Prior Bacillus Calmette-Guerin (BCG) Treatment No	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline disease assessment to best response disease assessment, measured up to 28 months.

Population: Of the 36 participants enrolled in the trial, one participant withdrew prior to reaching this endpoint.

To evaluate measurable disease overall response. Subjects were evaluated by CT scans at regular intervals for disease assessment by RECISTv1.1 criteria for the duration of treatment.

Response Evaluation Criteria in Solid Tumors (RECIST) is a standard measure of how well cancer patients respond to treatment. Possible scores are CR (Complete Response; total disappearance of all target lesions), PR (Partial Response; at least a 30% decrease of the sum of the longest diameter of all target lesions), PD (Progressive Disease; at least a 20% increase of the sum of the longest diameter of all target lesions), and SD (Stable Disease; neither a sufficient decrease for PR, or sufficient increase for PD). Overall response is the count of PR and CR scores among the participants' best RECISTv1.1 responses.

Outcome measures

Measure	Cabozantinib and Pembrolizumab, All Patients n=35 Participants Cabozantinib: Cabozantinib was administered at 40 mg oral daily. Pembrolizumab: Pembrolizumab was administered at a fixed dose of 200mg intravenously every 3 weeks.
Count of Participants With Response Measured by RECIST 1.1	16 Participants

SECONDARY outcome

Timeframe: Up to 34 months from the start of the study treatment.

Population: Of the 36 participants enrolled in the trial, one participant withdrew prior to reaching this endpoint.

To evaluate progression-free survival at completion of study follow-up (PFS). PFS is defined as the count of participants who remained alive and progression-free completion of their follow-up period. Participants were followed up to six months after completion of the study treatment.

Subjects were evaluated by CT scans at regular intervals for disease assessment by RECISTv1.1 criteria (as described in the primary outcome) for the duration of treatment.

Outcome measures

Measure	Cabozantinib and Pembrolizumab, All Patients n=35 Participants Cabozantinib: Cabozantinib was administered at 40 mg oral daily. Pembrolizumab: Pembrolizumab was administered at a fixed dose of 200mg intravenously every 3 weeks.
Count of Participants Who Were Progression-free at the Completion of Study Follow-up (PFS).	18 Participants

SECONDARY outcome

Timeframe: Up to 34 months from the start of the study treatment.

Population: Of the 36 participants enrolled in the trial, one participant was not evaluable for efficacy endpoints.

To evaluate Overall Survival (OS) at completion of study follow-up. OS is defined as the count of participants who remained alive after their follow-up period. Participants were followed up to six months after completion of the study treatment.

Subjects were followed via telephone contact or medical record review for survival 6 months after completing the study treatment.

Outcome measures

Measure	Cabozantinib and Pembrolizumab, All Patients n=35 Participants Cabozantinib: Cabozantinib was administered at 40 mg oral daily. Pembrolizumab: Pembrolizumab was administered at a fixed dose of 200mg intravenously every 3 weeks.
Count of Overall Survival (OS) at Completion of Study Follow-up	23 Participants

SECONDARY outcome

Timeframe: Up to 31 months from the start of study treatment.

Population: All participants who received the study drug were evaluated for adverse events and serious adverse events endpoints.

To evaluate toxicities associated with the combination treatment. Subjects were monitored for adverse events from the start of treatment through 30 days after the last dose of study treatment, and serious adverse events were collected until 90 days after the cessation of study treatment.

The severity of adverse events was assessed using CTCAE v5.0 criteria, a 1-5 scale with higher numbers indicating greater severity. Grade 1 indicates "mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated" and Grade 5 indicates "death related to AE". The treating investigator evaluated each adverse event to assess its attribution to the study treatment.

This outcome measure will report the following:

• The count of participants who had a grade 1-2 event, related to study treatment.
• The count of the participants who had a grade 3-4 event, related to study treatment.
• The count of the participants who had a grade 5 event or higher,

Outcome measures

Measure	Cabozantinib and Pembrolizumab, All Patients n=36 Participants Cabozantinib: Cabozantinib was administered at 40 mg oral daily. Pembrolizumab: Pembrolizumab was administered at a fixed dose of 200mg intravenously every 3 weeks.
Occurrence of Adverse Events and Serious Adverse Events Count of participants with a related grade 1-2 event.	23 Participants
Occurrence of Adverse Events and Serious Adverse Events Count of participants with a related grade 5 event or higher.	0 Participants
Occurrence of Adverse Events and Serious Adverse Events Count of participants with a related grade 3-4 event.	6 Participants

Adverse Events

Cabozantinib and Pembrolizumab, All Patients

Serious events: 22 serious events

Other events: 37 other events

Deaths: 12 deaths

Serious adverse events

Measure	Cabozantinib and Pembrolizumab, All Patients n=37 participants at risk Cabozantinib: Cabozantinib was administered at 40 mg oral daily. Pembrolizumab: Pembrolizumab was administered at a fixed dose of 200mg intravenously every 3 weeks.
Renal and urinary disorders Acute kidney injury	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Alanine aminotransferase increased	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Metabolism and nutrition disorders Anorexia	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Aspartate aminotransferase increased	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Cardiac disorders Atrial flutter	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Musculoskeletal and connective tissue disorders Back pain	2.7% 1/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Renal and urinary disorders Bladder perforation	2.7% 1/37 • Number of events 3 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Cardiac disorders Cardiac disorders - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Cardiac disorders Chest pain - cardiac	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Colonic perforation	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Constipation	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
General disorders Disease progression	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Nervous system disorders Encephalopathy	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Nervous system disorders Guillain-Barre syndrome	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Cardiac disorders Heart failure	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Renal and urinary disorders Hematuria	8.1% 3/37 • Number of events 3 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Infections and infestations Hepatitis viral	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Vascular disorders Hypotension	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Immune system disorders Immune system disorders - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Infections and infestations Infections and infestations - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Cardiac disorders Paroxysmal atrial tachycardia	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Rectal hemorrhage	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Renal and urinary disorders Renal and urinary disorders - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Infections and infestations Sepsis	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Vascular disorders Thromboembolic event	16.2% 6/37 • Number of events 6 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Infections and infestations Urinary tract infection	8.1% 3/37 • Number of events 4 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.

Other adverse events

Measure	Cabozantinib and Pembrolizumab, All Patients n=37 participants at risk Cabozantinib: Cabozantinib was administered at 40 mg oral daily. Pembrolizumab: Pembrolizumab was administered at a fixed dose of 200mg intravenously every 3 weeks.
Gastrointestinal disorders Abdominal distension	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Abdominal pain	10.8% 4/37 • Number of events 5 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Activated partial thromboplastin time prolonged	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Psychiatric disorders Agitation	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Alanine aminotransferase increased	10.8% 4/37 • Number of events 12 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Alkaline phosphatase increased	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Skin and subcutaneous tissue disorders Alopecia	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Blood and lymphatic system disorders Anemia	18.9% 7/37 • Number of events 10 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Metabolism and nutrition disorders Anorexia	35.1% 13/37 • Number of events 16 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Nervous system disorders Anosmia	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Psychiatric disorders Anxiety	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Musculoskeletal and connective tissue disorders Arthralgia	16.2% 6/37 • Number of events 9 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Aspartate aminotransferase increased	13.5% 5/37 • Number of events 12 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Musculoskeletal and connective tissue disorders Back pain	8.1% 3/37 • Number of events 3 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Renal and urinary disorders Bladder spasm	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Bloating	8.1% 3/37 • Number of events 3 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Blood bilirubin increased	2.7% 1/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Blood lactate dehydrogenase increased	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Eye disorders Blurred vision	8.1% 3/37 • Number of events 4 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Skin and subcutaneous tissue disorders Bullous dermatitis	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Cardiac disorders Cardiac disorders - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Cardiac troponin I increased	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Musculoskeletal and connective tissue disorders Chest wall pain	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
General disorders Chills	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Hepatobiliary disorders Cholecystitis	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Nervous system disorders Cognitive disturbance	2.7% 1/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Colitis	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Nervous system disorders Concentration impairment	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Psychiatric disorders Confusion	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Constipation	40.5% 15/37 • Number of events 17 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Cough	10.8% 4/37 • Number of events 4 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Creatinine increased	5.4% 2/37 • Number of events 3 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Psychiatric disorders Depression	2.7% 1/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Diarrhea	64.9% 24/37 • Number of events 42 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Nervous system disorders Dizziness	8.1% 3/37 • Number of events 4 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Eye disorders Dry eye	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Dry mouth	10.8% 4/37 • Number of events 4 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Skin and subcutaneous tissue disorders Dry skin	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Nervous system disorders Dysgeusia	21.6% 8/37 • Number of events 9 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Dyspnea	24.3% 9/37 • Number of events 10 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Renal and urinary disorders Dysuria	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Ear and labyrinth disorders Ear pain	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
General disorders Edema limbs	8.1% 3/37 • Number of events 4 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Electrocardiogram QT corrected interval prolonged	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Nervous system disorders Encephalopathy	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Endocrine disorders Endocrine disorders - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Eye disorders Eye disorders - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Eye disorders Eye pain	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Injury, poisoning and procedural complications Fall	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
General disorders Fatigue	62.2% 23/37 • Number of events 38 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Fecal incontinence	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
General disorders Fever	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Musculoskeletal and connective tissue disorders Flank pain	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Flatulence	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
General disorders Flu like symptoms	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
General disorders Gait disturbance	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Gastroesophageal reflux disease	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	10.8% 4/37 • Number of events 4 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
General disorders General disorders and administration site conditions - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
General disorders Generalized edema	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	8.1% 3/37 • Number of events 5 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Skin and subcutaneous tissue disorders Hair color changes	8.1% 3/37 • Number of events 3 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Nervous system disorders Headache	16.2% 6/37 • Number of events 6 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Renal and urinary disorders Hematuria	13.5% 5/37 • Number of events 10 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Hemorrhoids	8.1% 3/37 • Number of events 3 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Hoarseness	27.0% 10/37 • Number of events 12 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Metabolism and nutrition disorders Hypercalcemia	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Metabolism and nutrition disorders Hyperglycemia	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Metabolism and nutrition disorders Hyperkalemia	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Metabolism and nutrition disorders Hypermagnesemia	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Metabolism and nutrition disorders Hypernatremia	2.7% 1/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Endocrine disorders Hyperparathyroidism	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Vascular disorders Hypertension	13.5% 5/37 • Number of events 8 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Endocrine disorders Hyperthyroidism	5.4% 2/37 • Number of events 3 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Metabolism and nutrition disorders Hypocalcemia	8.1% 3/37 • Number of events 5 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Metabolism and nutrition disorders Hypoglycemia	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Metabolism and nutrition disorders Hypokalemia	8.1% 3/37 • Number of events 5 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Metabolism and nutrition disorders Hypomagnesemia	24.3% 9/37 • Number of events 11 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Metabolism and nutrition disorders Hyponatremia	5.4% 2/37 • Number of events 8 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Metabolism and nutrition disorders Hypophosphatemia	27.0% 10/37 • Number of events 24 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Vascular disorders Hypotension	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Endocrine disorders Hypothyroidism	24.3% 9/37 • Number of events 11 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Immune system disorders Immune system disorders - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Psychiatric disorders Insomnia	13.5% 5/37 • Number of events 6 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Investigations - Other, specify	29.7% 11/37 • Number of events 15 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Nervous system disorders Lethargy	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Lipase increased	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Infections and infestations Lung infection	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
General disorders Malaise	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Mucositis oral	24.3% 9/37 • Number of events 12 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Musculoskeletal and connective tissue disorders Muscle cramp	10.8% 4/37 • Number of events 4 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Musculoskeletal and connective tissue disorders Myalgia	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Nausea	51.4% 19/37 • Number of events 26 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
General disorders Non-cardiac chest pain	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Oral dysesthesia	18.9% 7/37 • Number of events 8 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Oral pain	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
General disorders Pain	16.2% 6/37 • Number of events 8 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Musculoskeletal and connective tissue disorders Pain in extremity	8.1% 3/37 • Number of events 3 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	37.8% 14/37 • Number of events 25 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Pancreatitis	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Nervous system disorders Paresthesia	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Reproductive system and breast disorders Pelvic pain	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Nervous system disorders Peripheral sensory neuropathy	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Platelet count decreased	5.4% 2/37 • Number of events 4 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.7% 1/37 • Number of events 3 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.7% 1/37 • Number of events 4 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Postnasal drip	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Productive cough	5.4% 2/37 • Number of events 3 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Renal and urinary disorders Proteinuria	13.5% 5/37 • Number of events 13 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Skin and subcutaneous tissue disorders Pruritus	35.1% 13/37 • Number of events 15 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Skin and subcutaneous tissue disorders Rash maculo-papular	8.1% 3/37 • Number of events 4 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Renal and urinary disorders Renal and urinary disorders - Other, specify	13.5% 5/37 • Number of events 7 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	2.7% 1/37 • Number of events 4 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Cardiac disorders Sinus tachycardia	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Infections and infestations Sinusitis	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	16.2% 6/37 • Number of events 11 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Skin and subcutaneous tissue disorders Skin atrophy	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Skin and subcutaneous tissue disorders Skin ulceration	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Sore throat	8.1% 3/37 • Number of events 4 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Injury, poisoning and procedural complications Spinal fracture	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Stomach pain	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Surgical and medical procedures Surgical and medical procedures - Other, specify	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Nervous system disorders Syncope	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Vascular disorders Thromboembolic event	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Infections and infestations Thrush	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Infections and infestations Upper respiratory infection	5.4% 2/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Renal and urinary disorders Urinary frequency	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Renal and urinary disorders Urinary retention	2.7% 1/37 • Number of events 2 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Infections and infestations Urinary tract infection	27.0% 10/37 • Number of events 15 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Renal and urinary disorders Urinary tract obstruction	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Urine output decreased	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Vascular disorders Vascular disorders - Other, specify	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Gastrointestinal disorders Vomiting	29.7% 11/37 • Number of events 13 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Investigations Weight loss	21.6% 8/37 • Number of events 12 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.
Respiratory, thoracic and mediastinal disorders Wheezing	2.7% 1/37 • Number of events 1 • Collection of Non-Serious Adverse Events (NSAE) began after informed consent and ended 30 days post the last dose of study treatment. Collection of Serious Adverse Events (SAE) began after informed consent and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated. Patients were followed for survival 6 months after study treatment. NSAEs were assessed up to 29 months, SAEs up to 31 months, and death up to 34 months from the start of treatment. Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected and recorded at every study visit.

Additional Information

IIT Data Management Team

Research Compliance Office, Huntsman Cancer Institute

Phone: 801-213-6215

Email: IITDataManagement@hci.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee Agreement with UNIVERSITY OF UTAH and MOFFITT CANCER CENTER: University and PI shall have first right to publish and disseminate the results of their investigative findings under the Study unless 18 months have elapsed following completion of the Study without such publication by University or PI. Agreement with UNIVERSITY OF UTAH and EMORY UNIVERSITY: University and PI shall have first right to publish and disseminate the results of their investigative findings under the Study.
• Publication restrictions are in place

Restriction type: OTHER