Trial Outcomes & Findings for Study of Pembrolizumab and Radiotherapy in Liver Cancer (NCT NCT03316872)

Last Updated: 2025-07-25

Results Overview

To assess the systemic efficacy of combined SBRT and pembrolizumab in subjects with advanced HCC who have experienced disease progression after previous therapy, as measured by overall response rate (ORR).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

3 years

Results posted on

2025-07-25

Participant Flow

18 patients of a planned 22 were enrolled

Participant milestones

Participant milestones
Measure	Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) Pembrolizumab, intravenously, at a dose of 200 mg, once every 3 weeks SBRT starting Day 2 of Cycle 1 of pembrolizumab treatment, given in 5 fractions over 10-15 days. Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Stereotactic Body Radiotherapy (SBRT): SBRT involves delivery of high doses of radiation therapy in smaller fractions
Overall Study STARTED	18
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) Pembrolizumab, intravenously, at a dose of 200 mg, once every 3 weeks SBRT starting Day 2 of Cycle 1 of pembrolizumab treatment, given in 5 fractions over 10-15 days. Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Stereotactic Body Radiotherapy (SBRT): SBRT involves delivery of high doses of radiation therapy in smaller fractions
Overall Study Death	1

Baseline Characteristics

Study of Pembrolizumab and Radiotherapy in Liver Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) n=18 Participants Pembrolizumab, intravenously, at a dose of 200 mg, once every 3 weeks SBRT starting Day 2 of Cycle 1 of pembrolizumab treatment, given in 5 fractions over 10-15 days. Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Stereotactic Body Radiotherapy (SBRT): SBRT involves delivery of high doses of radiation therapy in smaller fractions
Age, Continuous	66.5 years n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	17 Participants n=99 Participants
Race/Ethnicity, Customized Asian	5 participants n=99 Participants
Race/Ethnicity, Customized White	12 participants n=99 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=99 Participants
Region of Enrollment Canada	18 participants n=99 Participants
Number of participants with history of liver disease Hep B	3 Participants n=99 Participants
Number of participants with history of liver disease Hep C	6 Participants n=99 Participants
Number of participants with history of liver disease MASLD/Alcohol/other	9 Participants n=99 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Patients with histologically confirmed advanced HCC with a Childs-Pugh score of 5 or 6 and ECOG 0-1 were eligible. Patients must have progressed on one line of prior TKI therapy for advanced HCC. Patients had to have intrahepatic HCC, treatable with personalized SBRT (27.5 Gy to 50 Gy in 5 fractions). A maximum of 10 hepatic lesions could be treated with a total sum of tumor diameters \<20cm, with no limit on the extent of MVI (as long as it could be encompassed with SBRT.)

Outcome measures

Outcome measures
Measure	Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) n=17 Participants Pembrolizumab, intravenously, at a dose of 200 mg, once every 3 weeks SBRT starting Day 2 of Cycle 1 of pembrolizumab treatment, given in 5 fractions over 10-15 days. Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Stereotactic Body Radiotherapy (SBRT): SBRT involves delivery of high doses of radiation therapy in smaller fractions
Overall Response Rate	41 percentage of participants Interval 18.0 to 67.0

SECONDARY outcome

Timeframe: 3 years

To determine the progression-free survival (PFS), in subjects receiving combination treatment with pembrolizumab and SBRT for advanced HCC who have experienced disease progression after sorafenib therapy.

Outcome measures

Outcome measures
Measure	Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) n=17 Participants Pembrolizumab, intravenously, at a dose of 200 mg, once every 3 weeks SBRT starting Day 2 of Cycle 1 of pembrolizumab treatment, given in 5 fractions over 10-15 days. Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Stereotactic Body Radiotherapy (SBRT): SBRT involves delivery of high doses of radiation therapy in smaller fractions
Progression-free Survival	0.45 years Interval 0.233 to 0.825

SECONDARY outcome

Timeframe: 3 years

To determine the overall survival (OS) in subjects receiving combination treatment with pembrolizumab and SBRT for advanced HCC who have experienced disease progression after sorafenib therapy.

Outcome measures

Outcome measures
Measure	Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) n=17 Participants Pembrolizumab, intravenously, at a dose of 200 mg, once every 3 weeks SBRT starting Day 2 of Cycle 1 of pembrolizumab treatment, given in 5 fractions over 10-15 days. Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Stereotactic Body Radiotherapy (SBRT): SBRT involves delivery of high doses of radiation therapy in smaller fractions
Overall Survival Rate	1.05 years Interval 0.475 to 2.15

Adverse Events

Pembrolizumab and Stereotactic Body Radiotherapy (SBRT)

Serious events: 14 serious events

Other events: 18 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) n=18 participants at risk Pembrolizumab, intravenously, at a dose of 200 mg, once every 3 weeks SBRT starting Day 2 of Cycle 1 of pembrolizumab treatment, given in 5 fractions over 10-15 days. Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Stereotactic Body Radiotherapy (SBRT): SBRT involves delivery of high doses of radiation therapy in smaller fractions
Investigations Blood bilirubin increased grade 2	16.7% 3/18 • Number of events 3 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Blood bilirubin increased grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Blood bilirubin increased grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Renal and urinary disorders Acute kidney injury grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Tumor lysis syndrome grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Ascites grade 3	22.2% 4/18 • Number of events 5 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Aspartate aminotransferase increased grade 3	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Blood and lymphatic system disorders Febrile neutropenia grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Skin and subcutaneous tissue disorders RASH grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Generalized muscle weakness grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Cardiac disorders Atrial fibrillation grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Hepatobiliary disorders Hepatic failure grade 4	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Hepatobiliary disorders Hepatic failure grade 5	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis grade 3	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Cardiac disorders Myocarditis grade 4	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Cardiac disorders Myocarditis grade 5	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Alanine aminotransferase increased grade 3	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders MOUTH SORES grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Fever grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Acidosis grade 4	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Hyperglycemia grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Vomiting grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Dyspnea grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Dyspnea grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Chills grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Anorexia grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Flu like symptoms grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Cough grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Pancreatitis grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Infections and infestations Bone infection grade 3	11.1% 2/18 • Number of events 3 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Nervous system disorders Seizure grade 4	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Cardiac disorders Cardiac arrest grade 4	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Cardiac disorders Cardiac arrest grade 5	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Respiratory failure grade 5	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Arthritis grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Blood and lymphatic system disorders AML grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Edema limbs grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Blood and lymphatic system disorders Anemia grade 4	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Upper gastrointestinal hemorrhage grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Other adverse events

Other adverse events
Measure	Pembrolizumab and Stereotactic Body Radiotherapy (SBRT) n=18 participants at risk Pembrolizumab, intravenously, at a dose of 200 mg, once every 3 weeks SBRT starting Day 2 of Cycle 1 of pembrolizumab treatment, given in 5 fractions over 10-15 days. Pembrolizumab: Pembrolizumab is a humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Stereotactic Body Radiotherapy (SBRT): SBRT involves delivery of high doses of radiation therapy in smaller fractions
Gastrointestinal disorders Diarrhea grade 1	38.9% 7/18 • Number of events 9 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Diarrhea grade 2	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Anorexia grade 1	27.8% 5/18 • Number of events 6 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Anorexia grade 2	27.8% 5/18 • Number of events 5 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Anorexia grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Aspartate aminotransferase increased grade 1	66.7% 12/18 • Number of events 30 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Aspartate aminotransferase increased grade 2	38.9% 7/18 • Number of events 15 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Aspartate aminotransferase increased grade 3	16.7% 3/18 • Number of events 5 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Alkaline phosphatase increased grade 1	61.1% 11/18 • Number of events 19 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Alkaline phosphatase increased grade 2	16.7% 3/18 • Number of events 7 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Alanine aminotransferase increased grade 1	55.6% 10/18 • Number of events 22 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Alanine aminotransferase increased grade 2	27.8% 5/18 • Number of events 7 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Alanine aminotransferase increased grade 3	16.7% 3/18 • Number of events 3 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Colitis grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Vascular disorders Hypotension grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Vascular disorders Hypotension grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Creatinine increased grade 1	16.7% 3/18 • Number of events 5 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Fatigue grade 1	50.0% 9/18 • Number of events 13 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Fatigue grade 2	50.0% 9/18 • Number of events 12 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Psychiatric disorders Insomnia grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Abdominal distension grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Constipation grade 1	33.3% 6/18 • Number of events 9 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Constipation grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Constipation grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Blood bilirubin increased grade 1	38.9% 7/18 • Number of events 20 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Blood bilirubin increased grade 2	33.3% 6/18 • Number of events 11 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Blood bilirubin increased grade 3	16.7% 3/18 • Number of events 5 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Skin and subcutaneous tissue disorders Rash maculo-papular grade 1	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Skin and subcutaneous tissue disorders Rash maculo-papular grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Dehydration grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Dehydration grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Hyponatremia grade 1	27.8% 5/18 • Number of events 16 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Hyponatremia grade 3	22.2% 4/18 • Number of events 6 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Ascites grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Ascites grade 2	27.8% 5/18 • Number of events 5 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Ascites grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Abdominal pain grade 1	50.0% 9/18 • Number of events 9 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Abdominal pain grade 2	27.8% 5/18 • Number of events 6 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Abdominal pain grade 3	5.6% 1/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Edema limbs grade 1	22.2% 4/18 • Number of events 4 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Edema limbs grade 2	16.7% 3/18 • Number of events 3 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Vascular disorders Hypertension grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Vascular disorders Hypertension grade 2	16.7% 3/18 • Number of events 3 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Cardiac disorders Chest pain grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Reproductive system and breast disorders Breast pain grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Platelet count decreased grade 1	61.1% 11/18 • Number of events 20 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Platelet count decreased grade 2	33.3% 6/18 • Number of events 10 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Platelet count decreased grade 3	16.7% 3/18 • Number of events 3 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Chest wall pain grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Skin and subcutaneous tissue disorders Purpura grade 1	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Reproductive system and breast disorders Gynecomastia grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations INR increased grade 1	27.8% 5/18 • Number of events 9 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Hypocalcemia grade 1	38.9% 7/18 • Number of events 20 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Hypocalcemia grade 2	22.2% 4/18 • Number of events 7 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations White blood cell decreased grade 1	27.8% 5/18 • Number of events 17 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations White blood cell decreased grade 2	16.7% 3/18 • Number of events 11 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations White blood cell decreased grade 3	11.1% 2/18 • Number of events 3 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Endocrine disorders Hypothyroidism grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Neutrophil count decreased grade 1	11.1% 2/18 • Number of events 8 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Neutrophil count decreased grade 2	22.2% 4/18 • Number of events 5 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Neutrophil count decreased grade 3	11.1% 2/18 • Number of events 3 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Cough grade 1	27.8% 5/18 • Number of events 6 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Cough grade 2	11.1% 2/18 • Number of events 4 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Lymphocyte count decreased grade 1	33.3% 6/18 • Number of events 13 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Lymphocyte count decreased grade 2	50.0% 9/18 • Number of events 20 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Lymphocyte count decreased grade 3	50.0% 9/18 • Number of events 14 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Lymphocyte count decreased grade 4	5.6% 1/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Hypoalbuminemia grade 1	38.9% 7/18 • Number of events 26 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Hypoalbuminemia grade 2	22.2% 4/18 • Number of events 8 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Hypoalbuminemia grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Hypomagnesemia grade 1	33.3% 6/18 • Number of events 15 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Blood and lymphatic system disorders Anemia grade 1	50.0% 9/18 • Number of events 17 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Blood and lymphatic system disorders Anemia grade 2	27.8% 5/18 • Number of events 20 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Blood and lymphatic system disorders Anemia grade 3	22.2% 4/18 • Number of events 7 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Pain grade 1	16.7% 3/18 • Number of events 4 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Pain grade 2	5.6% 1/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Pain grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Pain in extremity grade 1	22.2% 4/18 • Number of events 4 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Pain in extremity grade 2	16.7% 3/18 • Number of events 3 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Pain in extremity grade 3	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Vomiting grade 1	16.7% 3/18 • Number of events 4 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Vomiting grade 2	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Vomiting grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Nervous system disorders Dizziness grade 1	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Dehydration grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Dehydration grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Skin and subcutaneous tissue disorders Pruritus grade 1	33.3% 6/18 • Number of events 9 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Skin and subcutaneous tissue disorders Pruritus grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Skin and subcutaneous tissue disorders Pruritus grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Skin and subcutaneous tissue disorders PRURIGO NODULES grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Back pain grade 1	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Back pain grade 2	5.6% 1/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Blood and lymphatic system disorders Lymph node pain grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Localized edema grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Pancreatitis grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Neck pain grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Non-cardiac chest pain grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Non-cardiac chest pain grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Dyspnea grade 1	16.7% 3/18 • Number of events 3 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Dyspnea grade 2	33.3% 6/18 • Number of events 6 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Dyspnea grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Lipase increased grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Lipase increased grade 4	5.6% 1/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Weight loss grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Weight loss grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Pleural effusion grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Hyperkalemia grade 1	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Hyperkalemia grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Hyperkalemia grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Myalgia grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Infections and infestations Lung infection grade 2	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Arthritis grade 1	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Hepatobiliary disorders LIVER PAIN grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Glucose intolerance grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis grade 1	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Flu like symptoms grade 1	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Flu like symptoms grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Dyspepsia grade 2	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Nausea grade 1	33.3% 6/18 • Number of events 8 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Nausea grade 2	27.8% 5/18 • Number of events 6 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Gastrointestinal pain grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Cardiac disorders Sinus bradycardia grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders JOINT STIFFNESS grade 1	5.6% 1/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Nervous system disorders Dysgeusia grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Nervous system disorders Dysgeusia grade 2	5.6% 1/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders REGURGITATION grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Malaise grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Dysphagia grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Sneezing grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Cardiac disorders Myocardial infarction grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Endocrine disorders Adrenal insufficiency grade 2	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Pain (General) grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Hyperglycemia grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Hyperglycemia grade 2	5.6% 1/18 • Number of events 3 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Hyperglycemia grade 3	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations TSH INCREASED grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Skin and subcutaneous tissue disorders RASH TO ARMS BILATERALLY grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders JOINT PAIN grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Skin and subcutaneous tissue disorders Rash acneiform grade 1	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Chills grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Edema face grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Gastroesophageal reflux disease grade 2	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Psychiatric disorders Confusion grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Psychiatric disorders Anxiety grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Dry mouth grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Skin and subcutaneous tissue disorders HEAT RASH grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Renal and urinary disorders URINARY TRACT PAIN grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Oral pain grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations LACTATE DEHYDROGENASE INCREASED grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Fever grade 1	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders Irritability grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Hepatobiliary disorders Hepatic failure grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Renal and urinary disorders Acute kidney injury grade 1	11.1% 2/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Renal and urinary disorders Acute kidney injury grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Infections and infestations Sepsis grade 4	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Eye disorders Cataract grade 3	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Bloating grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Bloating grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Investigations Activated partial thromboplastin time prolonged grade 1	5.6% 1/18 • Number of events 2 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Hypophosphatemia grade 2	22.2% 4/18 • Number of events 7 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Metabolism and nutrition disorders Hypophosphatemia grade 3	11.1% 2/18 • Number of events 4 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Cardiac disorders Atrial fibrillation	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Hiccups grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Infections and infestations Mucosal infection grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Joint effusion grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Eye disorders Blurred vision grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Nasal congestion grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Vascular disorders Thromboembolic event grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders BLOOD TRANSFUSION grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Skin and subcutaneous tissue disorders Photosensitivity grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Musculoskeletal and connective tissue disorders Arthralgia grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Vascular disorders Hematoma grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Gastrointestinal disorders Toothache grade 2	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Injury, poisoning and procedural complications Bruising grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Skin and subcutaneous tissue disorders Dry skin grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Eye disorders Dry eye grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
General disorders RHINORRHEA grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Respiratory, thoracic and mediastinal disorders Sore throat grade 1	5.6% 1/18 • Number of events 1 • 3 years, up to 36 months Adverse Events were recorded from the time of screening until 30 days after last dose. Adverse events (AEs) and treatment related adverse events (TRAEs) were recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Additional Information

Dr. Jennifer J Knox

Princess Margaret Cancer Centre

Phone: +1-416-946-2399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place