Trial Outcomes & Findings for Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery (NCT NCT02506153)
NCT ID: NCT02506153
Last Updated: 2025-11-10
Results Overview
Time from date of randomization to date of death due to any cause. Patients known to be alive are censored at date of last contact. The results were presented as 5-year OS estimate.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
1301 participants
Primary outcome timeframe
5 years after last randomization
Results posted on
2025-11-10
Participant Flow
1,301 participants were randomized (SOC arm=654 and Pembrolizumab arm=647). On the SOC arm, 40 participants assigned to HD-IFN didn't receive intervention (36 due to refusal and 4 due to other reasons) and 49 participants assigned to ipilimumab did not receive intervention (41 due to refusal, 2 due to early progression, and 6 due to other reasons). 8 participants assigned to Pembrolizumab didn't receive intervention (4 due to refusal, 2 due to early progression, and 2 due to other reasons).
Participant milestones
| Measure |
FDA Approved Regimen (SOC)
Participants receive physician/patient choice of either high-dose recombinant interferon alfa-2B (HD-IFN) or Ipilimumab as follows:
HD-IFN Induction: IV over 20 mins on days 1-5. Tx repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.
Maintenance: SC on days 1, 3, and 5. Tx repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab Induction: IV over 90 mins on day 1. Tx repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity.
Maintenance: IV over 90 mins on day 1. Tx repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity.
|
MK-3475 (Pembrolizumab)
Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
654
|
647
|
|
Overall Study
COMPLETED
|
52
|
366
|
|
Overall Study
NOT COMPLETED
|
602
|
281
|
Reasons for withdrawal
| Measure |
FDA Approved Regimen (SOC)
Participants receive physician/patient choice of either high-dose recombinant interferon alfa-2B (HD-IFN) or Ipilimumab as follows:
HD-IFN Induction: IV over 20 mins on days 1-5. Tx repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.
Maintenance: SC on days 1, 3, and 5. Tx repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab Induction: IV over 90 mins on day 1. Tx repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity.
Maintenance: IV over 90 mins on day 1. Tx repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity.
|
MK-3475 (Pembrolizumab)
Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Adverse Event
|
359
|
114
|
|
Overall Study
Refused unrelated to adverse event
|
127
|
18
|
|
Overall Study
Progression/relapse
|
91
|
136
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Other - not protocol specified
|
23
|
12
|
Baseline Characteristics
Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery
Baseline characteristics by cohort
| Measure |
FDA Approved Regimen (SOC)
n=654 Participants
Participants receive physician/patient choice of either high-dose recombinant interferon alfa-2B (HD-IFN) or Ipilimumab as follows:
HD-IFN Induction: IV over 20 mins on days 1-5. Tx repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.
Maintenance: SC on days 1, 3, and 5. Tx repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab Induction: IV over 90 mins on day 1. Tx repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity.
Maintenance: IV over 90 mins on day 1. Tx repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity.
|
MK-3475 (Pembrolizumab)
n=647 Participants
Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
|
Total
n=1301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Hispanic · Yes
|
18 Participants
n=5 Participants
|
26 Participants
n=20 Participants
|
44 Participants
n=40 Participants
|
|
Age, Continuous
|
57.0 years
n=5 Participants
|
55.9 years
n=20 Participants
|
56.75 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
259 Participants
n=5 Participants
|
264 Participants
n=20 Participants
|
523 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
395 Participants
n=5 Participants
|
383 Participants
n=20 Participants
|
778 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic · No
|
617 Participants
n=5 Participants
|
604 Participants
n=20 Participants
|
1221 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic · Unknown
|
19 Participants
n=5 Participants
|
17 Participants
n=20 Participants
|
36 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
621 Participants
n=5 Participants
|
622 Participants
n=20 Participants
|
1243 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
5 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
6 Participants
n=5 Participants
|
4 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Native American
|
0 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Multi-Racial
|
4 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
17 Participants
n=5 Participants
|
18 Participants
n=20 Participants
|
35 Participants
n=40 Participants
|
|
Stage
IIIA
|
69 Participants
n=5 Participants
|
76 Participants
n=20 Participants
|
145 Participants
n=40 Participants
|
|
Stage
IIIB
|
324 Participants
n=5 Participants
|
311 Participants
n=20 Participants
|
635 Participants
n=40 Participants
|
|
Stage
IIIC
|
222 Participants
n=5 Participants
|
220 Participants
n=20 Participants
|
442 Participants
n=40 Participants
|
|
Stage
IV
|
39 Participants
n=5 Participants
|
40 Participants
n=20 Participants
|
79 Participants
n=40 Participants
|
|
Performance Status
0
|
549 Participants
n=5 Participants
|
541 Participants
n=20 Participants
|
1090 Participants
n=40 Participants
|
|
Performance Status
1
|
105 Participants
n=5 Participants
|
106 Participants
n=20 Participants
|
211 Participants
n=40 Participants
|
|
Planned Control Arm Regimen
High Dose Interferon
|
154 Participants
n=5 Participants
|
153 Participants
n=20 Participants
|
307 Participants
n=40 Participants
|
|
Planned Control Arm Regimen
Ipilimumab
|
465 Participants
n=5 Participants
|
454 Participants
n=20 Participants
|
919 Participants
n=40 Participants
|
|
Planned Control Arm Regimen
Enrolled prior to amendment
|
35 Participants
n=5 Participants
|
40 Participants
n=20 Participants
|
75 Participants
n=40 Participants
|
|
PD-L1 Status
Positive
|
536 Participants
n=5 Participants
|
534 Participants
n=20 Participants
|
1070 Participants
n=40 Participants
|
|
PD-L1 Status
Negative
|
93 Participants
n=5 Participants
|
94 Participants
n=20 Participants
|
187 Participants
n=40 Participants
|
|
PD-L1 Status
Indeterminate
|
25 Participants
n=5 Participants
|
19 Participants
n=20 Participants
|
44 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 5 years after last randomizationPopulation: The analysis population includes the 1301 participants who were eligible and evaluable (654 in the SOC arm and 647 in the MK-3475 arm).
Time from date of randomization to date of death due to any cause. Patients known to be alive are censored at date of last contact. The results were presented as 5-year OS estimate.
Outcome measures
| Measure |
MK-3475 (Pembrolizumab)
n=647 Participants
Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
|
FDA Approved Regimen (SOC)
n=654 Participants
Participants receive physician/patient choice of either high-dose recombinant interferon alfa-2B (HD-IFN) or Ipilimumab as follows:
HD-IFN Induction: IV over 20 mins on days 1-5. Tx repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.
Maintenance: SC on days 1, 3, and 5. Tx repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab Induction: IV over 90 mins on day 1. Tx repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity.
Maintenance: IV over 90 mins on day 1. Tx repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
82 percentage of participants
Interval 78.0 to 84.0
|
76 percentage of participants
Interval 73.0 to 80.0
|
SECONDARY outcome
Timeframe: 5 years after last randomizationPopulation: The analysis population includes the 1301 participants who were eligible and evaluable (654 in the SOC arm and 647 in the MK-3475 arm).
Time from date of randomization to date of first documentation of relapse or death due to any cause. Patients last known to be alive and relapse-free are censored at date of last contact.
Outcome measures
| Measure |
MK-3475 (Pembrolizumab)
n=647 Participants
Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
|
FDA Approved Regimen (SOC)
n=654 Participants
Participants receive physician/patient choice of either high-dose recombinant interferon alfa-2B (HD-IFN) or Ipilimumab as follows:
HD-IFN Induction: IV over 20 mins on days 1-5. Tx repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.
Maintenance: SC on days 1, 3, and 5. Tx repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab Induction: IV over 90 mins on day 1. Tx repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity.
Maintenance: IV over 90 mins on day 1. Tx repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Relapse-free Survival (RFS)
|
58 percentage of participants
Interval 54.0 to 62.0
|
49 percentage of participants
Interval 45.0 to 53.0
|
SECONDARY outcome
Timeframe: 94 months; from study start November 10, 2015 to September 15, 2023Population: The analysis population includes the 1070 participants who were eligible and evaluable with a PDL-1 positive status (536 in the SOC arm and 534 in the MK-3475 arm).
Time from date of randomization to date of death due to any cause. Patients known to be alive are censored at date of last contact.
Outcome measures
| Measure |
MK-3475 (Pembrolizumab)
n=534 Participants
Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
|
FDA Approved Regimen (SOC)
n=536 Participants
Participants receive physician/patient choice of either high-dose recombinant interferon alfa-2B (HD-IFN) or Ipilimumab as follows:
HD-IFN Induction: IV over 20 mins on days 1-5. Tx repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.
Maintenance: SC on days 1, 3, and 5. Tx repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab Induction: IV over 90 mins on day 1. Tx repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity.
Maintenance: IV over 90 mins on day 1. Tx repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS) in Participants Who Are PD-L1 Positive
|
83 percentage of participants
Interval 80.0 to 86.0
|
79 percentage of participants
Interval 74.0 to 82.0
|
SECONDARY outcome
Timeframe: 5 years after last randomizationPopulation: The analysis population includes the 1070 participants who were eligible and evaluable with a PDL-1 positive status (536 in the SOC arm and 534 in the MK-3475 arm).
Time from date of randomization to date of first documentation of relapse or death due to any cause. Patients last known to be alive and relapse-free are censored at date of last contact.
Outcome measures
| Measure |
MK-3475 (Pembrolizumab)
n=534 Participants
Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
|
FDA Approved Regimen (SOC)
n=536 Participants
Participants receive physician/patient choice of either high-dose recombinant interferon alfa-2B (HD-IFN) or Ipilimumab as follows:
HD-IFN Induction: IV over 20 mins on days 1-5. Tx repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.
Maintenance: SC on days 1, 3, and 5. Tx repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab Induction: IV over 90 mins on day 1. Tx repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity.
Maintenance: IV over 90 mins on day 1. Tx repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Relapse-free Survival (RFS) in Participants Who Are PD-L1 Positive
|
60 percentage of participants
Interval 56.0 to 64.0
|
51 percentage of participants
Interval 46.0 to 55.0
|
SECONDARY outcome
Timeframe: Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.Population: Participants who were eligible and received at least one dose of protocol treatment.
Only adverse events that are possibly, probably or definitely related to study drug are reported. CTCAE Version 5.0 was used for all AE reporting.
Outcome measures
| Measure |
MK-3475 (Pembrolizumab)
n=639 Participants
Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
|
FDA Approved Regimen (SOC)
n=565 Participants
Participants receive physician/patient choice of either high-dose recombinant interferon alfa-2B (HD-IFN) or Ipilimumab as follows:
HD-IFN Induction: IV over 20 mins on days 1-5. Tx repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.
Maintenance: SC on days 1, 3, and 5. Tx repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab Induction: IV over 90 mins on day 1. Tx repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity.
Maintenance: IV over 90 mins on day 1. Tx repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Tremor
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vitreous hemorrhage
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
1 Participants
|
9 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight loss
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Wheezing
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
White blood cell decreased
|
0 Participants
|
19 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain of skin
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pancreatitis
|
5 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Papulopustular rash
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Peripheral motor neuropathy
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Peripheral sensory neuropathy
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pharyngitis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pleural effusion
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pneumonitis
|
4 Participants
|
5 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Proteinuria
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pruritus
|
0 Participants
|
6 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash acneiform
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash maculo-papular
|
9 Participants
|
31 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash pustular
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Resp, thoracic and mediastinal disorders - Other
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Respiratory failure
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Restrictive cardiomyopathy
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Retinal detachment
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Retinal tear
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Seizure
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sepsis
|
1 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Serum amylase increased
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sinus tachycardia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sinusitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Skin and subcutaneous tissue disorders - Other
|
2 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Skin infection
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Syncope
|
1 Participants
|
6 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Atelectasis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Atrial fibrillation
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Autoimmune disorder
|
1 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Back pain
|
0 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Blood and lymphatic system disorders - Other
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Blood bilirubin increased
|
2 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Blurred vision
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bone pain
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bronchospasm
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
CPK increased
|
2 Participants
|
5 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac disorders - Other, specify
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac troponin T increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Colitis
|
13 Participants
|
35 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Colonic perforation
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Confusion
|
1 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cough
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Creatinine increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cystitis noninfective
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
1 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Depression
|
0 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
18 Participants
|
54 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dizziness
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Duodenal ulcer
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspepsia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea
|
4 Participants
|
12 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Encephalitis infection
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Encephalopathy
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Endocrine disorders - Other, specify
|
2 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Enterocolitis
|
1 Participants
|
6 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Enterocolitis infectious
|
1 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Erectile dysfunction
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Esophagitis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Eye disorders - Other, specify
|
1 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Eye pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Facial nerve disorder
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fall
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue
|
3 Participants
|
30 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Febrile neutropenia
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Flu like symptoms
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Forced expiratory volume decreased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
GGT increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastritis
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastrointestinal disorders - Other, specify
|
0 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
General disorders and admin site conditions - Other
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Generalized muscle weakness
|
0 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Headache
|
3 Participants
|
12 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hepatic pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hepatitis viral
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hepatobiliary disorders - Other, specify
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hiccups
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperglycemia
|
7 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypersomnia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
2 Participants
|
7 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperthyroidism
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertriglyceridemia
|
1 Participants
|
8 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoalbuminemia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypokalemia
|
0 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyponatremia
|
9 Participants
|
14 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypophosphatemia
|
3 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypotension
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypothyroidism
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoxia
|
2 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Immune system disorders - Other, specify
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infections and infestations - Other, specify
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infusion related reaction
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Insomnia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Joint effusion
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Leukemia secondary to oncology chemotherapy
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Leukocytosis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lipase increased
|
1 Participants
|
5 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lower gastrointestinal hemorrhage
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lung infection
|
4 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count decreased
|
3 Participants
|
14 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Meningitis
|
0 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Metabolism and nutrition disorders - Other, specify
|
1 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis oral
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Muscle weakness lower limb
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Musculoskeletal and connective tiss disorder - Other
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myalgia
|
1 Participants
|
5 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myocardial infarction
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myocarditis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myositis
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
1 Participants
|
9 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nervous system disorders - Other, specify
|
2 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neuralgia
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutrophil count decreased
|
2 Participants
|
51 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain in extremity
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Abdominal pain
|
2 Participants
|
6 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acidosis
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acute kidney injury
|
2 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Adrenal insufficiency
|
4 Participants
|
9 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alanine aminotransferase increased
|
19 Participants
|
44 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alkaline phosphatase increased
|
0 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anemia
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
1 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anxiety
|
0 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arthralgia
|
3 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arthritis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Aspartate aminotransferase increased
|
14 Participants
|
33 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Atrial flutter
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Proctitis
|
1 Participants
|
0 Participants
|
Adverse Events
FDA Approved Regimen
Serious events: 23 serious events
Other events: 557 other events
Deaths: 130 deaths
MK-3475 (Pembrolizumab)
Serious events: 125 serious events
Other events: 622 other events
Deaths: 131 deaths
Serious adverse events
| Measure |
FDA Approved Regimen
n=565 participants at risk
Participants receive physician/patient choice of either high-dose recombinant interferon alfa-2B (HD-IFN) or Ipilimumab as follows:
HD-IFN Induction: IV over 20 mins on days 1-5. Tx repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.
Maintenance: SC on days 1, 3, and 5. Tx repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab Induction: IV over 90 mins on day 1. Tx repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity.
Maintenance: IV over 90 mins on day 1. Tx repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity.
89 participants did not receive ant protocol treatment and were not evaluable for adverse events, however they were included in the All-Cause Mortality "at Risk" population.
|
MK-3475 (Pembrolizumab)
n=639 participants at risk
Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
8 participants did not receive ant protocol treatment and were not evaluable for adverse events, however they were included in the All-Cause Mortality "at Risk" population.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.63%
4/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.47%
3/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.94%
6/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Endocrine disorders
Endocrine disorders-Other
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Eye disorders
Blurred vision
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Eye disorders
Eye disorders-Other
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.00%
0/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Eye disorders
Eye pain
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Eye disorders
Uveitis
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.78%
5/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
1.6%
10/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
1.9%
12/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.35%
2/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Jejunal obstruction
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.78%
5/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
General disorders
Fatigue
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
General disorders
Fever
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
General disorders
Flu like symptoms
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
General disorders
Infusion related reaction
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
General disorders
Non-cardiac chest pain
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
General disorders
Pain
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.47%
3/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Immune system disorders
Autoimmune disorder
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.00%
0/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Immune system disorders
Immune system disorders-Other
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Encephalitis infection
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.00%
0/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Infections and infestations-Other
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.47%
3/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Lung infection
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.78%
5/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Sepsis
|
0.35%
2/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Skin infection
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
1.3%
8/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
2.3%
15/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
1.6%
10/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.47%
3/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
CPK increased
|
0.35%
2/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Creatinine increased
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Lipase increased
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.00%
0/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Neutrophil count decreased
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Platelet count decreased
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
White blood cell decreased
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.00%
0/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.94%
6/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.35%
2/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.71%
4/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.94%
6/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.00%
0/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.00%
0/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia secondary to oncology chemotherapy
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Nervous system disorders
Nervous system disorders-Other
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Nervous system disorders
Seizure
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal conditions-Other
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.47%
3/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.00%
0/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.00%
0/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.18%
1/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
1.3%
8/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
1.4%
9/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic and mediastinal disorders - Other
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.35%
2/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.00%
0/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.47%
3/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Social circumstances
Social circumstances-Other
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Surgical and medical procedures
Surgical and medical procedures-Other
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Vascular disorders
Hematoma
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Vascular disorders
Hypertension
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Vascular disorders
Hypotension
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.31%
2/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Vascular disorders
Vascular disorders-Other
|
0.00%
0/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
0.16%
1/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
Other adverse events
| Measure |
FDA Approved Regimen
n=565 participants at risk
Participants receive physician/patient choice of either high-dose recombinant interferon alfa-2B (HD-IFN) or Ipilimumab as follows:
HD-IFN Induction: IV over 20 mins on days 1-5. Tx repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.
Maintenance: SC on days 1, 3, and 5. Tx repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.
Ipilimumab Induction: IV over 90 mins on day 1. Tx repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity.
Maintenance: IV over 90 mins on day 1. Tx repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity.
89 participants did not receive ant protocol treatment and were not evaluable for adverse events, however they were included in the All-Cause Mortality "at Risk" population.
|
MK-3475 (Pembrolizumab)
n=639 participants at risk
Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
8 participants did not receive ant protocol treatment and were not evaluable for adverse events, however they were included in the All-Cause Mortality "at Risk" population.
|
|---|---|---|
|
General disorders
Pain
|
9.0%
51/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
11.4%
73/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Blood and lymphatic system disorders
Anemia
|
22.8%
129/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
18.0%
115/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
5.1%
29/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
3.4%
22/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Endocrine disorders
Endocrine disorders-Other
|
9.2%
52/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
4.4%
28/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
3.4%
19/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
8.5%
54/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Endocrine disorders
Hypothyroidism
|
12.2%
69/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
22.4%
143/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Eye disorders
Blurred vision
|
6.4%
36/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
5.2%
33/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Eye disorders
Eye disorders-Other
|
6.0%
34/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
4.5%
29/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
106/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
13.6%
87/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Colitis
|
9.6%
54/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
2.0%
13/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Constipation
|
18.2%
103/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
16.1%
103/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Diarrhea
|
52.2%
295/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
36.8%
235/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
7.4%
42/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
10.2%
65/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
6.0%
34/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
6.6%
42/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Nausea
|
45.3%
256/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
30.0%
192/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Gastrointestinal disorders
Vomiting
|
19.5%
110/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
10.6%
68/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
General disorders
Chills
|
23.4%
132/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
8.6%
55/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
General disorders
Edema limbs
|
6.0%
34/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
8.8%
56/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
General disorders
Fatigue
|
63.9%
361/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
67.1%
429/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
General disorders
Fever
|
23.9%
135/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
9.7%
62/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
General disorders
Flu like symptoms
|
10.8%
61/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
6.7%
43/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
General disorders
General disorders and admin site conditions - Other
|
5.8%
33/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
4.5%
29/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
General disorders
Non-cardiac chest pain
|
2.8%
16/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
5.0%
32/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Infections and infestations-Other
|
6.0%
34/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
5.9%
38/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Sinusitis
|
1.8%
10/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
6.1%
39/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Infections and infestations
Upper respiratory infection
|
5.1%
29/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
8.8%
56/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Alanine aminotransferase increased
|
39.3%
222/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
16.1%
103/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Alkaline phosphatase increased
|
10.8%
61/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
7.7%
49/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
38.8%
219/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
20.0%
128/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Blood bilirubin increased
|
6.9%
39/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
6.9%
44/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Creatinine increased
|
9.4%
53/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
11.3%
72/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Investigations-Other
|
9.4%
53/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
10.2%
65/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Lymphocyte count decreased
|
10.4%
59/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
10.8%
69/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Neutrophil count decreased
|
19.8%
112/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
3.9%
25/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Platelet count decreased
|
17.2%
97/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
6.3%
40/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
Weight loss
|
18.4%
104/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
5.9%
38/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Investigations
White blood cell decreased
|
17.0%
96/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
8.6%
55/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Anorexia
|
31.5%
178/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
11.3%
72/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.3%
41/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
3.3%
21/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.0%
85/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
17.7%
113/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.5%
31/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
8.5%
54/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
10.4%
59/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
11.7%
75/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.5%
93/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
9.1%
58/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.0%
51/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
4.9%
31/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.3%
13/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
5.2%
33/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.8%
61/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
7.5%
48/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.5%
93/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
11.7%
75/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.2%
80/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
22.5%
144/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.6%
43/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
8.5%
54/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.9%
39/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
2.8%
18/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tiss disorder - Other
|
3.7%
21/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
6.4%
41/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.7%
100/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
15.3%
98/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.5%
48/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
10.8%
69/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
3.2%
18/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
7.0%
45/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Nervous system disorders
Dizziness
|
18.2%
103/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
11.1%
71/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Nervous system disorders
Dysgeusia
|
9.7%
55/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
5.2%
33/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Nervous system disorders
Headache
|
44.1%
249/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
28.2%
180/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Nervous system disorders
Paresthesia
|
2.1%
12/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
5.2%
33/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
35/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
5.8%
37/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Psychiatric disorders
Anxiety
|
8.3%
47/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
9.1%
58/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Psychiatric disorders
Depression
|
8.3%
47/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
6.3%
40/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Psychiatric disorders
Insomnia
|
14.9%
84/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
11.4%
73/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.6%
9/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
5.2%
33/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
103/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
24.9%
159/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
87/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
13.9%
89/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.5%
37/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
14.1%
90/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.8%
33/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
8.9%
57/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.3%
41/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
4.2%
27/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.6%
43/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
8.5%
54/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.2%
176/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
26.8%
171/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.5%
37/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
6.1%
39/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.4%
228/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
32.7%
209/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
11.2%
63/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
18.2%
116/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Vascular disorders
Hypertension
|
10.4%
59/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
17.5%
112/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
|
Vascular disorders
Hypotension
|
5.8%
33/565 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
1.7%
11/639 • Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
CTCAE version 5.0 was used for reporting toxicities and SAEs. There were 565 participants in the standard-of-care group and 639 participants in the pembrolizumab group that were evaluable for AEs.
|
Additional Information
Melanoma Committee Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60