Trial Outcomes & Findings for Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor (NCT NCT03239145)

NCT ID: NCT03239145

Last Updated: 2026-07-01

Results Overview

A standard 3+3 dose-escalation design was used during dose escalation period. DLT was defined in protocol section 5.5.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

62 participants

Primary outcome timeframe

3 weeks

Results posted on

2026-07-01

Participant Flow

Participants were enrolled from May 2018 to February 2021.

Participant milestones

Participant milestones
Measure	Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Escalation Dose Level I] Pembrolizumab + Trebananib Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.	[Dose Escalation Dose Level II] Pembrolizumab + Trebananib Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal) Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian) Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly
Overall Study STARTED	4	4	3	39	12
Overall Study Treated	4	3	3	37	11
Overall Study Outcome Analytic Cohort	4	0	3	37	11
Overall Study COMPLETED	0	0	1	1	0
Overall Study NOT COMPLETED	4	4	2	38	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Escalation Dose Level I] Pembrolizumab + Trebananib Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.	[Dose Escalation Dose Level II] Pembrolizumab + Trebananib Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal) Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian) Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly
Overall Study Did not get treated	0	1	0	2	1
Overall Study Disease Progression	3	3	2	33	10
Overall Study Physician Decision	0	0	0	1	0
Overall Study No Restaging Scans	1	0	0	0	0
Overall Study Adverse Event	0	0	0	2	1

Baseline Characteristics

Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	[Dose Level I] Pembrolizumab + Trebananib n=3 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Colorectal) n=40 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Ovarian) n=11 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) n=4 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	Total n=58 Participants Total of all reporting groups
Race/Ethnicity, Customized Asian	0 Participants n=9 Participants	4 Participants n=27 Participants	2 Participants n=267 Participants	0 Participants n=265 Participants	6 Participants n=568 Participants
Age, Continuous	40.8 Years n=9 Participants	53.8 Years n=27 Participants	63.6 Years n=267 Participants	56.3 Years n=265 Participants	55.4 Years n=568 Participants
Sex: Female, Male Female	2 Participants n=9 Participants	17 Participants n=27 Participants	11 Participants n=267 Participants	2 Participants n=265 Participants	32 Participants n=568 Participants
Sex: Female, Male Male	1 Participants n=9 Participants	23 Participants n=27 Participants	0 Participants n=267 Participants	2 Participants n=265 Participants	26 Participants n=568 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants	1 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	1 Participants n=568 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=9 Participants	32 Participants n=27 Participants	11 Participants n=267 Participants	4 Participants n=265 Participants	50 Participants n=568 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	7 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	7 Participants n=568 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=9 Participants	3 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	3 Participants n=568 Participants
Race/Ethnicity, Customized Other	0 Participants n=9 Participants	1 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants	1 Participants n=568 Participants
Race/Ethnicity, Customized White	3 Participants n=9 Participants	32 Participants n=27 Participants	9 Participants n=267 Participants	4 Participants n=265 Participants	48 Participants n=568 Participants
ECOG Performance Status Performance Status 0	1 Participants n=9 Participants	26 Participants n=27 Participants	5 Participants n=267 Participants	2 Participants n=265 Participants	34 Participants n=568 Participants
ECOG Performance Status Performance Status 1	2 Participants n=9 Participants	14 Participants n=27 Participants	6 Participants n=267 Participants	2 Participants n=265 Participants	24 Participants n=568 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: DLTs will be monitored and collected for treated participants that enrolled during the dose escalation period.

A standard 3+3 dose-escalation design was used during dose escalation period. DLT was defined in protocol section 5.5.

Outcome measures

Outcome measures
Measure	[Dose Level II] Pembrolizumab + Trebananib (Ovarian) n=3 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Colorectal) n=3 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
Number of Participants Experienced Dose Limit Toxicities (DLT)	0 Participants	—	0 Participants

PRIMARY outcome

Timeframe: 3 weeks

Population: This analysis applies only to patients who were enrolled and treated during the dose-escalation period.

MTD will be defined as the dose level at which fewer than one-third of participants experience a dose-limiting toxicity attributable to pembrolizumab and trebananib, as determined using a standard 3+3 dose-escalation design.

Outcome measures

Outcome measures
Measure	[Dose Level II] Pembrolizumab + Trebananib (Ovarian) Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Colorectal) n=6 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
Maximum Tolerated Dose (MTD) of Trebananib	—	—	30 mg/kg

PRIMARY outcome

Timeframe: The median follow up time was 3.3 months (range: 0.6 to 25.3 months).

Population: This analysis only included participants enrolled and treated during the dose expansion period.

The percentage of participants who experienced grade 3 or higher adverse event based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4).

Outcome measures

Outcome measures
Measure	[Dose Level II] Pembrolizumab + Trebananib (Ovarian) n=11 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) n=4 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Colorectal) n=37 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
Grade 3 or Higher Toxicity Rate in Expansion Cohort	63.6 percentage of participants Interval 35.0 to 86.5	75.0 percentage of participants Interval 24.9 to 98.7	59.5 percentage of participants Interval 44.6 to 73.1

SECONDARY outcome

Timeframe: Median follow-up was 29.3 months (range 0.9 - 42.0 months).

Population: The analysis population will include patients enrolled in the dose escalation and dose expansion portions of the trial. Per protocol, the dose escalation and dose expansion data may be combined for patients with the same cancer type who received the same treatment doses.

ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

Outcome measures

Outcome measures
Measure	[Dose Level II] Pembrolizumab + Trebananib (Ovarian) n=11 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) n=4 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Colorectal) n=40 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
Objective Response Rate (ORR)	9.1 percentage of participants Interval 0.1 to 36.4	0 percentage of participants Interval 0.0 to 52.7	7.5 percentage of participants Interval 2.1 to 18.3

SECONDARY outcome

Timeframe: 6 months

PFS6 is the percent probability estimate at 6 months based on the Kaplan-Meier method. PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.

Outcome measures

Outcome measures
Measure	[Dose Level II] Pembrolizumab + Trebananib (Ovarian) n=11 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) n=4 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Colorectal) n=40 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
Progression Free Survival at 6 Months (PFS6)	9 percentage probability Interval 1.0 to 33.0	50 percentage probability Interval 6.0 to 84.0	13 percentage probability Interval 5.0 to 25.0

SECONDARY outcome

Timeframe: 1 year

OS1 is the percent probability estimate at 1 year based on the Kaplan-Meier method. OS is defined as the time from or registration to death due to any cause, or censored at date last known alive.

Outcome measures

Outcome measures
Measure	[Dose Level II] Pembrolizumab + Trebananib (Ovarian) n=11 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) n=4 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Colorectal) n=40 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
Overall Survival at 1 Year (OS1)	80 percentage of participants Interval 38.0 to 95.0	50 percentage of participants Interval 6.0 to 84.0	45 percentage of participants Interval 28.0 to 61.0

SECONDARY outcome

Timeframe: Median follow-up was 29.3 months (range 0.9 - 42.0 months).

TTP based on Kaplan-Meier method is defined as the time from registration to progression disease (PD), or censored at date of last disease evaluation for those without progression reported. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.

Outcome measures

Outcome measures
Measure	[Dose Level II] Pembrolizumab + Trebananib (Ovarian) n=11 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) n=4 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level II] Pembrolizumab + Trebananib (Colorectal) n=40 Participants Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
Median Time To Progression (TTP)	3.1 Months Interval 3.0 to 3.8	4.4 Months Interval 1.2 to The upper bound of the TTP 90% confidence interval was not reached due to insufficient events at the time of analysis.	3.1 Months Interval 2.8 to 3.2

Adverse Events

Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 4 deaths

[Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal)

Serious events: 14 serious events

Other events: 40 other events

Deaths: 22 deaths

Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian)

Serious events: 4 serious events

Other events: 11 other events

Deaths: 5 deaths

[Dose Level I] Pembrolizumab + Trebananib

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

F. Stephen Hodi, MD

Dana-Farber Cancer Institute

Phone: (617) 632-5053

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) n=4 participants at risk Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal) n=40 participants at risk Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian) n=11 participants at risk Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level I] Pembrolizumab + Trebananib n=3 participants at risk Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.
Blood and lymphatic system disorders Anemia	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Cardiac disorders Pericardial effusion	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	9.1% 1/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	5.0% 2/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Colitis	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	9.1% 1/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Diarrhea	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	9.1% 1/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Vomiting	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
General disorders and administration site conditions Edema limbs	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	9.1% 1/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
General disorders and administration site conditions Fever	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	5.0% 2/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
General disorders and administration site conditions Localized edema	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	9.1% 1/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Infections and infestations Biliary tract infection	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	33.3% 1/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Infections and infestations Lung infection	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Infections and infestations Sepsis	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Investigations Alanine aminotransferase increased	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Investigations Alkaline phosphatase increased	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Investigations Blood bilirubin increased	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Investigations GGT increased	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	33.3% 1/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Investigations Lipase increased	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Metabolism and nutrition disorders Hyponatremia	25.0% 1/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Nervous system disorders Headache	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Nervous system disorders Syncope	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Renal and urinary disorders Urinary retention	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	9.1% 1/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	9.1% 1/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	5.0% 2/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Vascular disorders Thromboembolic event	25.0% 1/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.

Other adverse events
Measure	Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma) n=4 participants at risk Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal) n=40 participants at risk Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian) n=11 participants at risk Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.	[Dose Level I] Pembrolizumab + Trebananib n=3 participants at risk Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.
Blood and lymphatic system disorders Anemia	100.0% 4/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	52.5% 21/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	45.5% 5/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	66.7% 2/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	5.0% 2/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Cardiac disorders Conduction disorder	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Cardiac disorders Chest pain - cardiac	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Cardiac disorders Palpitations	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Cardiac disorders Sinus bradycardia	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	5.0% 2/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Cardiac disorders Sinus tachycardia	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	15.0% 6/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	27.3% 3/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	66.7% 2/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Endocrine disorders Hyperthyroidism	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	25.0% 10/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	18.2% 2/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Endocrine disorders Hypothyroidism	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	32.5% 13/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	36.4% 4/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	33.3% 1/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Eye disorders Blurred vision	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	5.0% 2/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	18.2% 2/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Eye disorders Photophobia	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Eye disorders Watering eyes	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	9.1% 1/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Eye disorders Eye disorders - Other, specify	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	5.0% 2/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Abdominal distension	25.0% 1/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	20.0% 8/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	36.4% 4/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	33.3% 1/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	35.0% 14/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	27.3% 3/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	33.3% 1/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Ascites	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	10.0% 4/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	27.3% 3/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Bloating	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	7.5% 3/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Colitis	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	18.2% 2/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Colonic fistula	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Constipation	25.0% 1/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	32.5% 13/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	36.4% 4/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	33.3% 1/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Dental caries	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Diarrhea	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	25.0% 10/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	36.4% 4/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Dry mouth	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	15.0% 6/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	9.1% 1/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	7.5% 3/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	9.1% 1/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Dysphagia	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	5.0% 2/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Esophagitis	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	5.0% 2/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Hemorrhoids	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	9.1% 1/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Mucositis oral	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	5.0% 2/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	9.1% 1/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Nausea	25.0% 1/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	42.5% 17/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	36.4% 4/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Rectal pain	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	2.5% 1/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	5.0% 2/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Vomiting	25.0% 1/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	25.0% 10/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	27.3% 3/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/4 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	7.5% 3/40 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	9.1% 1/11 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.	0.00% 0/3 • The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months. A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.