Trial Outcomes & Findings for Cabozantinib in Advanced Pancreatic Neuroendocrine and Carcinoid Tumors (NCT NCT01466036)

Last Updated: 2024-03-05

Results Overview

The objective response rate of cabozantinib was evaluated according to RECIST v 1.1 criteria (Response Evaluation Criteria In Solid Tumors v 1.1). Disease was assessed using CT and/or MRI scans. RECIST 1.1 criteria include the following categories of disease response: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% or more decrease in the sum of the longest diameter of target lesions; Stable disease (SD) = less than 30% decrease but no more than 20% increase in sum of the longest diameter of target lesions. Objective response rate consisted of CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

Imaging was performed cycles 2,4,6 every 8 weeks for the first 24 weeks, then every 3rd cycle every 12 weeks until progression or EOT. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Cycle=28 days.

Results posted on

2024-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Metastatic or Unresectable PNET patients with pancreatic neuroendocrine tumors receiving cabozantinib Cabozantinib: 60 mg QD orally in cycles of 28 days	Metastatic or Unresectable Carcinoid patients with advanced or metastatic carcinoid tumor receiving cabozantinib Cabozantinib: 60 mg QD orally in cycles of 28 days
Overall Study STARTED	20	41
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	20	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Metastatic or Unresectable PNET patients with pancreatic neuroendocrine tumors receiving cabozantinib Cabozantinib: 60 mg QD orally in cycles of 28 days	Metastatic or Unresectable Carcinoid patients with advanced or metastatic carcinoid tumor receiving cabozantinib Cabozantinib: 60 mg QD orally in cycles of 28 days
Overall Study Death	1	1
Overall Study Physician Decision	0	4
Overall Study Adverse Event	2	6
Overall Study Withdrawal by Subject	2	8
Overall Study progression/relapse	14	21
Overall Study prolonged treatment delay	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metastatic or Unresectable PNET n=20 Participants Patients with pancreatic neuroendocrine tumors receiving cabozantinib Cabozantinib: 60 mg QD orally in cycles of 28 days	Metastatic or Unresectable Carcinoid n=41 Participants Patients with advanced or metastatic carcinoid tumor receiving cabozantinib Cabozantinib: 60 mg QD orally in cycles of 28 days	Total n=61 Participants Total of all reporting groups
Age, Continuous	55 years n=20 Participants	63 years n=41 Participants	60 years n=61 Participants
Sex: Female, Male Female	8 Participants n=20 Participants	23 Participants n=41 Participants	31 Participants n=61 Participants
Sex: Female, Male Male	12 Participants n=20 Participants	18 Participants n=41 Participants	30 Participants n=61 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Imaging was performed cycles 2,4,6 every 8 weeks for the first 24 weeks, then every 3rd cycle every 12 weeks until progression or EOT. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Cycle=28 days.

Population: Response rate by RECIST 1.1 was calculated by including all patients who started study therapy.

Outcome measures

Outcome measures
Measure	Metastatic or Unresectable PNET n=20 Participants patients with pancreatic neuroendocrine tumors receiving cabozantinib Cabozantinib: 60 mg QD orally in cycles of 28 days	Metastatic or Unresectable Carcinoid n=41 Participants Patients with advanced or metastatic carcinoid tumor receiving cabozantinib Cabozantinib: 60 mg QD orally in cycles of 28 days
Objective Response Rate (ORR)	3 Participants	7 Participants

SECONDARY outcome

Timeframe: Restaging imaging was performed after cycles 2, 4, and 6 (every 8 weeks for the first 24 weeks), then every 3rd cycle (every 12 weeks) until disease progression or end of study treatment. Median follow-up is 89.1 months. Cycle = 28 days.

Progression-free survival was defined as time in months from initiation of treatment until disease progression by RECIST 1.1 criteria or death from any cause. Progressive disease by RECIST 1.1 criteria is defined as at least a 20% increase in the sum of the longest dimensions of target lesions, taking as reference the smallest sum of longest dimensions recorded since the treatment started; the appearance of one or more new lesions; unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Metastatic or Unresectable PNET n=20 Participants patients with pancreatic neuroendocrine tumors receiving cabozantinib Cabozantinib: 60 mg QD orally in cycles of 28 days	Metastatic or Unresectable Carcinoid n=41 Participants Patients with advanced or metastatic carcinoid tumor receiving cabozantinib Cabozantinib: 60 mg QD orally in cycles of 28 days
Progression Free Survival (PFS)	21.1 months Interval 8.6 to 32.0	17.6 months Interval 8.3 to 23.8

SECONDARY outcome

Timeframe: Median follow-up time of 89.1 months.

Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.

Outcome measures

Outcome measures
Measure	Metastatic or Unresectable PNET n=20 Participants patients with pancreatic neuroendocrine tumors receiving cabozantinib Cabozantinib: 60 mg QD orally in cycles of 28 days	Metastatic or Unresectable Carcinoid n=41 Participants Patients with advanced or metastatic carcinoid tumor receiving cabozantinib Cabozantinib: 60 mg QD orally in cycles of 28 days
Overall Survival (OS)	37.3 months Interval 14.5 to 70.7	36.1 months Interval 20.6 to 65.5

Adverse Events

Metastatic or Unresectable PNET

Serious events: 15 serious events

Other events: 20 other events

Deaths: 1 deaths

Metastatic or Unresectable Carcinoid

Serious events: 24 serious events

Other events: 41 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Jennifer Chan

Dana-Farber Cancer Institute

Phone: 617-632-6315

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Metastatic or Unresectable PNET n=20 participants at risk patients were stratified by primary tumor site but received the same treatment. This cohort had pancreatic neuroendocrine tumors. Cabozantinib: 60 mg QD orally in cycles of 28 days	Metastatic or Unresectable Carcinoid n=41 participants at risk Patients were stratified by primary tumor site but received the same treatment. This cohort had advanced or metastatic carcinoid tumor. Cabozantinib: 60 mg QD orally in cycles of 28 days
Gastrointestinal disorders Abdominal pain	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	0.00% 0/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Alanine aminotransferase increased	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Gastrointestinal disorders Anal fistula	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	0.00% 0/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Blood and lymphatic system disorders Anemia	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Metabolism and nutrition disorders Anorexia	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Aspartate aminotransferase increased	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Immune system disorders Autoimmune disorder	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Gastrointestinal disorders Diarrhea	15.0% 3/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	7.3% 3/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
General disorders Edema limbs	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
General disorders Fatigue	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	7.3% 3/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Vascular disorders Hypertension	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	19.5% 8/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Metabolism and nutrition disorders Hypomagnesemia	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	0.00% 0/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Metabolism and nutrition disorders Hyponatremia	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Metabolism and nutrition disorders Hypophosphatemia	15.0% 3/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	12.2% 5/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Infections and infestations Infections and infestations - Other, specify	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Lipase increased	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	9.8% 4/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Lymphocyte count decreased	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	9.8% 4/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Gastrointestinal disorders Nausea	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Neutrophil count decreased	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
General disorders Pain	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	0.00% 0/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Platelet count decreased	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	7.3% 3/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Renal and urinary disorders Proteinuria	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Renal and urinary disorders Renal and urinary disorders - Other, specify	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Cardiac disorders Restrictive cardiomyopathy	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	0.00% 0/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Serum amylase increased	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	4.9% 2/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Infections and infestations Skin infection	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	0.00% 0/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Gastrointestinal disorders Small intestinal perforation	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	0.00% 0/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Weight loss	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations White blood cell decreased	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests

Other adverse events
Measure	Metastatic or Unresectable PNET n=20 participants at risk patients were stratified by primary tumor site but received the same treatment. This cohort had pancreatic neuroendocrine tumors. Cabozantinib: 60 mg QD orally in cycles of 28 days	Metastatic or Unresectable Carcinoid n=41 participants at risk Patients were stratified by primary tumor site but received the same treatment. This cohort had advanced or metastatic carcinoid tumor. Cabozantinib: 60 mg QD orally in cycles of 28 days
Gastrointestinal disorders Abdominal distension	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	12.2% 5/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Gastrointestinal disorders Abdominal pain	50.0% 10/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	48.8% 20/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Activated partial thromboplastin time prolonged	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	7.3% 3/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Renal and urinary disorders Acute kidney injury	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Nervous system disorders Akathisia	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	4.9% 2/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Alanine aminotransferase increased	70.0% 14/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	43.9% 18/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Alkaline phosphatase increased	50.0% 10/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	48.8% 20/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Skin and subcutaneous tissue disorders Alopecia	15.0% 3/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	14.6% 6/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Gastrointestinal disorders Anal hemorrhage	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Gastrointestinal disorders Anal pain	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Blood and lymphatic system disorders Anemia	55.0% 11/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	56.1% 23/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Metabolism and nutrition disorders Anorexia	50.0% 10/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	29.3% 12/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Psychiatric disorders Anxiety	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	0.00% 0/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Musculoskeletal and connective tissue disorders Arthritis	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	0.00% 0/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Gastrointestinal disorders Ascites	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	12.2% 5/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Aspartate aminotransferase increased	75.0% 15/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	73.2% 30/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Musculoskeletal and connective tissue disorders Back pain	20.0% 4/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	17.1% 7/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	10.0% 2/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Blood antidiuretic hormone abnormal	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	0.00% 0/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Blood bilirubin increased	20.0% 4/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	4.9% 2/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Eye disorders Blurred vision	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Infections and infestations Bronchial infection	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Injury, poisoning and procedural complications Bruising	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Musculoskeletal and connective tissue disorders Buttock pain	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Cardiac disorders Chest pain - cardiac	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	0.00% 0/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
General disorders Chills	10.0% 2/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	0.00% 0/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Cholesterol high	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	4.9% 2/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Nervous system disorders Cognitive disturbance	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Gastrointestinal disorders Colitis	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Gastrointestinal disorders Colonic obstruction	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	0.00% 0/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Psychiatric disorders Confusion	0.00% 0/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	7.3% 3/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Eye disorders Conjunctivitis	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	0.00% 0/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Gastrointestinal disorders Constipation	15.0% 3/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	22.0% 9/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Respiratory, thoracic and mediastinal disorders Cough	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	4.9% 2/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Investigations Creatinine increased	5.0% 1/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	2.4% 1/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests
Metabolism and nutrition disorders Dehydration	10.0% 2/20 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests	7.3% 3/41 • Participants were followed for AEs and SAEs starting from the first dose of study treatment, throughout the study, and through 30 days from the last study treatment. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Patients were followed for AEs during the time on treatment plus 30 days (median of 9.6 months). Participants were followed for All-Cause Mortality for longer (median 89.1 months). Adverse Event (AE): An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Abnormal laboratory values or diagnostic test results constitute adverse events only if they are determined to be of clinical significance or require treatment or further diagnostic tests