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: 2026-03-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
62 participants
Primary outcome timeframe
3 weeks
Results posted on
2026-03-12
Participant Flow
Participants were enrolled from May 2018 to February 2021.
Participant milestones
| Measure |
[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
|
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.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
39
|
12
|
4
|
|
Overall Study
Treated
|
3
|
3
|
37
|
11
|
4
|
|
Overall Study
Outcome Analytic Cohort
|
0
|
3
|
37
|
11
|
4
|
|
Overall Study
COMPLETED
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
38
|
12
|
4
|
Reasons for withdrawal
| Measure |
[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
|
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.
|
|---|---|---|---|---|---|
|
Overall Study
Did not get treated
|
1
|
0
|
2
|
1
|
0
|
|
Overall Study
Disease Progression
|
3
|
2
|
33
|
10
|
3
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
No Restaging Scans
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
1
|
0
|
Baseline Characteristics
Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor
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
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.8 Years
n=9 Participants
|
53.8 Years
n=9 Participants
|
63.6 Years
n=18 Participants
|
56.3 Years
n=15 Participants
|
55.4 Years
n=60 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
17 Participants
n=9 Participants
|
11 Participants
n=18 Participants
|
2 Participants
n=15 Participants
|
32 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9 Participants
|
23 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=15 Participants
|
26 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=9 Participants
|
32 Participants
n=9 Participants
|
11 Participants
n=18 Participants
|
4 Participants
n=15 Participants
|
50 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
7 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
2 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
6 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
3 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=9 Participants
|
32 Participants
n=9 Participants
|
9 Participants
n=18 Participants
|
4 Participants
n=15 Participants
|
48 Participants
n=60 Participants
|
|
ECOG Performance Status
Performance Status 0
|
1 Participants
n=9 Participants
|
26 Participants
n=9 Participants
|
5 Participants
n=18 Participants
|
2 Participants
n=15 Participants
|
34 Participants
n=60 Participants
|
|
ECOG Performance Status
Performance Status 1
|
2 Participants
n=9 Participants
|
14 Participants
n=9 Participants
|
6 Participants
n=18 Participants
|
2 Participants
n=15 Participants
|
24 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: 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
| Measure |
[Dose Escalation 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.
Pembrolizumab: Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
Trebananib: AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
|
[Dose Escalation Dose Level II] Pembrolizumab + Trebananib
n=3 Participants
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
Pembrolizumab: Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
Trebananib: AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
|
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.
|
|---|---|---|---|
|
Number of Participants Experienced Dose Limit Toxicities (DLT)
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: 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
| Measure |
[Dose Escalation Dose Level I] Pembrolizumab + Trebananib
n=6 Participants
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.
Pembrolizumab: Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
Trebananib: AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
|
[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.
Pembrolizumab: Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
Trebananib: AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
|
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.
|
|---|---|---|---|
|
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 event based on the Common Toxicity Criteria for Adverse Events Version 4.0 (CTCAEv4).
Outcome measures
| Measure |
[Dose Escalation Dose Level I] Pembrolizumab + Trebananib
n=37 Participants
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.
Pembrolizumab: Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
Trebananib: AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
|
[Dose Escalation Dose Level II] Pembrolizumab + Trebananib
n=11 Participants
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
Pembrolizumab: Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
Trebananib: AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
|
Dose Expansion 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.
|
|---|---|---|---|
|
Grade 3 or Higher Toxicity Rate in Expansion Cohort
|
59.5 percentage of participants
Interval 44.6 to 73.1
|
63.6 percentage of participants
Interval 35.0 to 86.5
|
75.0 percentage of participants
Interval 24.9 to 98.7
|
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
| Measure |
[Dose Escalation Dose Level I] Pembrolizumab + Trebananib
n=40 Participants
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.
Pembrolizumab: Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
Trebananib: AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
|
[Dose Escalation Dose Level II] Pembrolizumab + Trebananib
n=11 Participants
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
Pembrolizumab: Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
Trebananib: AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
|
Dose Expansion 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.
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
7.5 percentage of participants
Interval 2.1 to 18.3
|
9.1 percentage of participants
Interval 0.1 to 36.4
|
0 percentage of participants
Interval 0.0 to 52.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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
| Measure |
[Dose Escalation Dose Level I] Pembrolizumab + Trebananib
n=40 Participants
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.
Pembrolizumab: Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
Trebananib: AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
|
[Dose Escalation Dose Level II] Pembrolizumab + Trebananib
n=11 Participants
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
Pembrolizumab: Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
Trebananib: AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
|
Dose Expansion 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.
|
|---|---|---|---|
|
Progression Free Survival at 6 Months (PFS6)
|
13 percentage probability
Interval 5.0 to 25.0
|
9 percentage probability
Interval 1.0 to 33.0
|
50 percentage probability
Interval 6.0 to 84.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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.
OS1 is the percent probability estimate at 1 year based on the Kaplan-Meier method. O is defined as the time from start of trial treatment to death from any cause. For patients who are lost to follow-up or who have no documentation of death at the time of final analysis, follow-up will be censored at the date of last assessment of vital status. 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
| Measure |
[Dose Escalation Dose Level I] Pembrolizumab + Trebananib
n=40 Participants
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.
Pembrolizumab: Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
Trebananib: AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
|
[Dose Escalation Dose Level II] Pembrolizumab + Trebananib
n=11 Participants
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
Pembrolizumab: Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
Trebananib: AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
|
Dose Expansion 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.
|
|---|---|---|---|
|
Overall Survival at 1 Year (OS1)
|
45 percentage of participants
Interval 28.0 to 61.0
|
80 percentage of participants
Interval 38.0 to 95.0
|
50 percentage of participants
Interval 6.0 to 84.0
|
SECONDARY outcome
Timeframe: ian 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.
TTP based on Kaplan-Meier method is defined as the time interval between the dates of the start of trial treatment and first documentation of progressive disease. In the absence of documented progressive disease, follow-up would be censored at date of last disease assessment. Deaths without prior progression would be censored events.
Outcome measures
| Measure |
[Dose Escalation Dose Level I] Pembrolizumab + Trebananib
n=40 Participants
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.
Pembrolizumab: Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
Trebananib: AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
|
[Dose Escalation Dose Level II] Pembrolizumab + Trebananib
n=11 Participants
Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
Pembrolizumab: Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
Trebananib: AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
|
Dose Expansion 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.
|
|---|---|---|---|
|
Median Time To Progression (TTP)
|
3.1 Months
Interval 2.8 to 3.2
|
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.
|
Adverse Events
[Dose Level I] Pembrolizumab + Trebananib
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 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 Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
[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.
|
[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 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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Cardiac disorders
Pericardial effusion
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Abdominal pain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Colitis
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Diarrhea
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Vomiting
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
General disorders and administration site conditions
Edema limbs
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
General disorders and administration site conditions
Fever
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
General disorders and administration site conditions
Localized edema
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Infections and infestations
Biliary tract infection
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Infections and infestations
Lung infection
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Infections and infestations
Sepsis
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Alanine aminotransferase increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Alkaline phosphatase increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Aspartate aminotransferase increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Blood bilirubin increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
GGT increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Lipase increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Nervous system disorders
Headache
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Nervous system disorders
Syncope
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Renal and urinary disorders
Acute kidney injury
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Renal and urinary disorders
Urinary retention
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Vascular disorders
Thromboembolic event
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
Other adverse events
| Measure |
[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.
|
[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 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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Cardiac disorders
Chest pain - cardiac
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Cardiac disorders
Conduction disorder
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Cardiac disorders
Palpitations
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Cardiac disorders
Sinus bradycardia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Cardiac disorders
Sinus tachycardia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Endocrine disorders
Hyperthyroidism
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Endocrine disorders
Hypothyroidism
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Eye disorders
Blurred vision
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Eye disorders
Photophobia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Eye disorders
Watering eyes
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Eye disorders
Eye disorders - Other, specify
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Abdominal distension
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Abdominal pain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Ascites
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Bloating
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Colitis
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Colonic fistula
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Constipation
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Dental caries
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Diarrhea
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Dry mouth
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Dyspepsia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Dysphagia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Esophagitis
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Hemorrhoids
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Mucositis oral
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Nausea
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Rectal pain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Vomiting
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
General disorders and administration site conditions
Chills
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
17.5%
7/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
General disorders and administration site conditions
Edema face
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
General disorders and administration site conditions
Edema limbs
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
17.5%
7/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
72.7%
8/11 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
General disorders and administration site conditions
Edema trunk
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
General disorders and administration site conditions
Fatigue
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
47.5%
19/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
General disorders and administration site conditions
Fever
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
22.5%
9/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
General disorders and administration site conditions
Gait disturbance
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
General disorders and administration site conditions
Infusion related reaction
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
General disorders and administration site conditions
Localized edema
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
12.5%
5/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
General disorders and administration site conditions
Pain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Hepatobiliary disorders
Cholecystitis
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Immune system disorders
Allergic reaction
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Infections and infestations
Bladder infection
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Infections and infestations
Lung infection
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Infections and infestations
Mucosal infection
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Infections and infestations
Sinusitis
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Infections and infestations
Skin infection
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Infections and infestations
Upper respiratory infection
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Infections and infestations
Urinary tract infection
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Infections and infestations
Vaginal infection
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Injury, poisoning and procedural complications
Bruising
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Injury, poisoning and procedural complications
Fall
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
27.5%
11/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Alanine aminotransferase increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
47.5%
19/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Alkaline phosphatase increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
57.5%
23/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Aspartate aminotransferase increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
50.0%
20/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Blood bilirubin increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Cardiac troponin T increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Creatinine increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
INR increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
17.5%
7/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
50.0%
2/4 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Lipase increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Lymphocyte count decreased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Neutrophil count decreased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Platelet count decreased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Serum amylase increased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Weight gain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Weight loss
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
White blood cell decreased
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
12.5%
5/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Investigations
Investigations - Other, specify
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Alkalosis
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Anorexia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
22.5%
9/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Dehydration
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
17.5%
7/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
3/3 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
40.0%
16/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
63.6%
7/11 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
50.0%
2/4 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
54.5%
6/11 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
45.0%
18/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
54.5%
6/11 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
17.5%
7/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
12.5%
5/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
17.5%
7/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Nervous system disorders
Neuralgia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Nervous system disorders
Dizziness
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Nervous system disorders
Headache
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
12.5%
5/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Nervous system disorders
Paresthesia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Nervous system disorders
Presyncope
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Psychiatric disorders
Anxiety
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Psychiatric disorders
Depression
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Psychiatric disorders
Insomnia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
12.5%
5/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Renal and urinary disorders
Acute kidney injury
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Renal and urinary disorders
Bladder spasm
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Renal and urinary disorders
Chronic kidney disease
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Renal and urinary disorders
Cystitis noninfective
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Renal and urinary disorders
Hematuria
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
22.5%
9/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Renal and urinary disorders
Proteinuria
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
47.5%
19/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Renal and urinary disorders
Urinary frequency
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Renal and urinary disorders
Urinary incontinence
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Renal and urinary disorders
Urinary retention
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Renal and urinary disorders
Urinary tract pain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Reproductive system and breast disorders
Breast pain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Reproductive system and breast disorders
Genital edema
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Reproductive system and breast disorders
Pelvic pain
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
17.5%
7/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
50.0%
2/4 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
50.0%
2/4 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
12.5%
5/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
22.5%
9/40 • 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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Vascular disorders
Hot flashes
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Vascular disorders
Hypertension
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Vascular disorders
Hypotension
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Vascular disorders
Peripheral ischemia
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Vascular disorders
Thromboembolic event
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
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 occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some adverse events not meeting the ICH definition, such as new cancers, are also considered serious by Merck and Amgen for reporting to comply with local regulatory requirements.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place