Trial Outcomes & Findings for Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer (NCT NCT02689284)

Last Updated: 2025-03-17

Results Overview

Characterize maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of margetuximab when administered in combination with pembrolizumab

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

95 participants

Primary outcome timeframe

21 days

Results posted on

2025-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) combination treatment is administered once every 21-day cycle
Overall Study STARTED	3	92
Overall Study COMPLETED	0	5
Overall Study NOT COMPLETED	3	87

Reasons for withdrawal

Reasons for withdrawal
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) combination treatment is administered once every 21-day cycle
Overall Study Adverse Event	1	8
Overall Study Death	0	1
Overall Study Physician Decision	1	2
Overall Study Withdrawal by Subject	0	1
Overall Study progression of cancer	1	72
Overall Study decreased heart function	0	1
Overall Study concern for anemia	0	1
Overall Study no measurable cancer for evaluation	0	1

Baseline Characteristics

Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 Participants combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 Participants combination treatment is administered once every 21-day cycle	Total n=95 Participants Total of all reporting groups
Age, Continuous	62.7 years STANDARD_DEVIATION 9.87 • n=5 Participants	60.2 years STANDARD_DEVIATION 12.83 • n=7 Participants	60.3 years STANDARD_DEVIATION 12.71 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	75 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	88 Participants n=7 Participants	91 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	51 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	34 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Canada	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment South Korea	0 participants n=5 Participants	42 participants n=7 Participants	42 participants n=5 Participants
Region of Enrollment Singapore	0 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	38 participants n=7 Participants	41 participants n=5 Participants
Region of Enrollment Taiwan	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
ECOG Performance Status 0	0 participants n=5 Participants	33 participants n=7 Participants	33 participants n=5 Participants
ECOG Performance Status 1	3 participants n=5 Participants	59 participants n=7 Participants	62 participants n=5 Participants
Primary tumor location Gastric	0 participants n=5 Participants	61 participants n=7 Participants	61 participants n=5 Participants
Primary tumor location Gastroesophageal junction	3 participants n=5 Participants	31 participants n=7 Participants	34 participants n=5 Participants
HER2 status using immunohistochemistry (IHC) IHC 2+	2 Participants n=5 Participants	21 Participants n=7 Participants	23 Participants n=5 Participants
HER2 status using immunohistochemistry (IHC) IHC 3+	1 Participants n=5 Participants	71 Participants n=7 Participants	72 Participants n=5 Participants
PD-L1 Status PD-L1 positive	1 Participants n=5 Participants	33 Participants n=7 Participants	34 Participants n=5 Participants
PD-L1 Status PD-L1 negative	1 Participants n=5 Participants	43 Participants n=7 Participants	44 Participants n=5 Participants
PD-L1 Status unknown	1 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants
HER2 IHC 3+ and PD-L1 positive	0 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Dose escalation cohorts to determine the expansion cohort dose.

Characterize maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of margetuximab when administered in combination with pembrolizumab

Outcome measures

Outcome measures
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 Participants combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=6 Participants combination treatment is administered once every 21-day cycle
Number of Patients With Dose Limiting Toxicities	0 Participants	0 Participants

PRIMARY outcome

Timeframe: up to 24 months

Population: All patients receiving at least 1 dose of margetuximab or pembrolizumab

The number of patients that experience either an AE or a SAE during the study participation

Outcome measures

Outcome measures
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 Participants combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 Participants combination treatment is administered once every 21-day cycle
Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs).	3 Participants	86 Participants

PRIMARY outcome

Timeframe: 12 months

Investigate the preliminary anti-tumor activity as measured by response to treatment of margetuximab when administered in combination with pembrolizumab, using conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Outcome measures

Outcome measures
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 Participants combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 Participants combination treatment is administered once every 21-day cycle
Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment	0 Participants	18 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: Analysis is limited to patients receiving margetuximab (15 mg/kg) and pembrolizumab (200 mg)

Investigate the preliminary anti-tumor activity, as measured by objective response rate (ORR) of margetuximab when administered in combination with pembrolizumab, using immune-related response criteria (irRC).

Outcome measures

Outcome measures
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 Participants combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 Participants combination treatment is administered once every 21-day cycle
Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment Using irRC Criteria	0 Participants	19 Participants

PRIMARY outcome

Timeframe: up to 24 months

Population: There were no responders in the 10mg/kg group

Duration of response is calculated at the time from CR or PR to relapse or cancer progression.

Outcome measures

Outcome measures
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 Participants combination treatment is administered once every 21-day cycle
Duration of Response	—	12.1 months Interval 2.79 to 26.68

SECONDARY outcome

Timeframe: 24 Months

The median length of time between first dose of study medication and death from any cause.

Outcome measures

Outcome measures
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 Participants combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 Participants combination treatment is administered once every 21-day cycle
Overall Survival (OS)	7.0 months Interval 2.37 to 9.66	12.7 months Interval 9.07 to 14.62

SECONDARY outcome

Timeframe: 24 Months

The interval between the first dose of study medication and progression of disease or death from any cause.

Outcome measures

Outcome measures
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 Participants combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 Participants combination treatment is administered once every 21-day cycle
Progression Free Survival (PFS)	1.4 months Interval 1.31 to 2.76	2.7 months Interval 0.37 to 4.34

SECONDARY outcome

Timeframe: from first dose to the end of treatment, average about 12 months

Population: Analysis was not performed. A number of samples were degraded in shipping rendering insufficient samples to conduct the analysis.

The planned assessment included examination of markers of T-cell activation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: from first dose to the end of treatment, average 12 months.

Population: Sample collection was planned for the Margetuximab (15 mg/kg) plus pembrolizumab (200 mg) cohort only. No samples were received that could be tested. The analysis could not be conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Day 1 of every odd cycle, and end of treatment visit, average 12 months

Outcome measures

Outcome measures
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 Participants combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 Participants combination treatment is administered once every 21-day cycle
Number of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab (Immunogenicity)	1 Participants	4 Participants

SECONDARY outcome

Timeframe: At end of infusion on Cycle 1, Day 1. Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months

Measurement of PK characteristics is limited to margetuximab. No analysis of pembrolizumab was conducted.

Outcome measures

Outcome measures
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 Participants combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 Participants combination treatment is administered once every 21-day cycle
Maximum Concentration of Margetuximab at Steady State	197 mcg/mL Geometric Coefficient of Variation 0.249	318 mcg/mL Geometric Coefficient of Variation 0.168

SECONDARY outcome

Timeframe: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months

AUC is a mathematical calculation that describes the variation in drug concentration in the blood over time.

Outcome measures

Outcome measures
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 Participants combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 Participants combination treatment is administered once every 21-day cycle
Area Under the Concentration Time Curve at Steady State (AUC ss)	1710 mcg/mL* day Geometric Coefficient of Variation 0.358	2720 mcg/mL* day Geometric Coefficient of Variation 0.329

SECONDARY outcome

Timeframe: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months.

Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time.

Outcome measures

Outcome measures
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 Participants combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 Participants combination treatment is administered once every 21-day cycle
Clearance	0.381 liters per day Geometric Coefficient of Variation 0.0394	0.329 liters per day Geometric Coefficient of Variation 0.296

SECONDARY outcome

Timeframe: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit average 12 months .

The volume of distribution is related to a whether how much drug is distributed to body tissues, or remains in the bloodstream.

Outcome measures

Outcome measures
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 Participants combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 Participants combination treatment is administered once every 21-day cycle
Volume of Distribution at Steady State	7.7 liters Geometric Coefficient of Variation 0.306	6.37 liters Geometric Coefficient of Variation 0.205

SECONDARY outcome

Timeframe: Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit average 12 months .

Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium.

Outcome measures

Outcome measures
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 Participants combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 Participants combination treatment is administered once every 21-day cycle
Terminal Half-life	17.2 day Geometric Coefficient of Variation 0.312	16.2 day Geometric Coefficient of Variation 0.286

Adverse Events

Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)

Serious events: 38 serious events

Other events: 86 other events

Deaths: 69 deaths

Serious adverse events

Other adverse events

Additional Information

VP, Scientific Communications

TerSera Therapeutics LLC

Phone: 1-844-334-4035

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 participants at risk combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 participants at risk combination treatment is administered once every 21-day cycle
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	9.8% 9/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Endocrine disorders Hypophysitis	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Obstruction gastric	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	4.3% 4/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	2.2% 2/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Oesophageal haemorrhage	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	2.2% 2/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	2.2% 2/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	2.2% 2/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Ascites	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Ileus	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Vomiting	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
General disorders Pyrexia	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	2.2% 2/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
General disorders Asthenia	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
General disorders Fatigue	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	2.2% 2/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Hepatobiliary disorders Biliary obstruction	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Infections and infestations Cellulitis	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	2.2% 2/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Infections and infestations Pneumonia	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	2.2% 2/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Infections and infestations Eye infection	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	33.3% 1/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	0.00% 0/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Infections and infestations Influenza	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Infections and infestations Liver abscess	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Infections and infestations Osteomyelitis	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Infections and infestations Peritonitis	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Infections and infestations Renal abscess	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	0.00% 0/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Nervous system disorders Headache	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Nervous system disorders Seizure	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Nervous system disorders Syncope	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	1.1% 1/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.

Other adverse events
Measure	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg) n=3 participants at risk combination treatment is administered once every 21-day cycle	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg) n=92 participants at risk combination treatment is administered once every 21-day cycle
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	31.5% 29/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	28.3% 26/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Nausea	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	25.0% 23/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	17.4% 16/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Vomiting	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	17.4% 16/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	13.0% 12/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Constipation	33.3% 1/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	10.9% 10/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	8.7% 8/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	7.6% 7/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	6.5% 6/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
General disorders Fatigue	33.3% 1/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	27.2% 25/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
General disorders Oedema peripheral	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	10.9% 10/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
General disorders Pyrexia	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	8.7% 8/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	6.5% 6/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Injury, poisoning and procedural complications Infusion related reaction	33.3% 1/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	13.0% 12/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Investigations Weight decreased	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	12.0% 11/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Investigations Amylase increased	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	7.6% 7/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	6.5% 6/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Investigations Lipase increased	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	6.5% 6/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Investigations Alanine aminotransferase increased	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	5.4% 5/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Investigations Blood creatinine increased	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	5.4% 5/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	17.4% 16/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	13.0% 12/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	6.5% 6/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	13.0% 12/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	5.4% 5/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	5.4% 5/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Nervous system disorders Dizziness	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	5.4% 5/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	5.4% 5/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Psychiatric disorders Insomnia	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	13.0% 12/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	14.1% 13/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	6.5% 6/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	19.6% 18/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	9.8% 9/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.	8.7% 8/92 • All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months. Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.