Trial Outcomes & Findings for A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11) (NCT NCT06099782)
NCT ID: NCT06099782
Last Updated: 2026-04-08
Results Overview
The PPQ is an instrument that has been developed from participant interviews and includes questions to evaluate directly from participants their preference regarding mode of administration, as well as the strength of the preference, and the reason for the preference. The PPQ does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the PPQ evaluates participants' preferred method of administration with response options of IV, SC or "no preference". As pre-specified by the protocol, the percentage of participants who preferred SC administration (participant preference rate \[PPR\]) was reported out of all randomized participants who received all 3 doses of Pembrolizumab IV and Pembrolizumab SC during treatment crossover period and answered at least question 1 of the PPQ on Cycle 6 Day 1 (Day 106).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
Day 106
Results posted on
2026-04-08
Participant Flow
147 participants were randomized to Treatment Arm A (n=71) or Treatment Arm B (n=76). Treatment Arms were defined per protocol as treatment sequence arms.
Participant milestones
| Measure |
Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV
In Treatment Crossover Period 1 participants first received pembrolizumab plus berahyaluronidase alfa subcutaneously (SC) for three 21-day cycles, followed by pembrolizumab intravenously (IV) for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for renal cell carcinoma (RCC) and melanoma, and for up to 35 21-day cycles (up to \~2 years) for non-small cell lung cancer (NSCLC).
|
Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC
In Treatment Crossover Period 1 participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to \~2 years) for NSCLC.
|
|---|---|---|
|
Treatment Crossover Period 1: Cycles 1-3
STARTED
|
71
|
76
|
|
Treatment Crossover Period 1: Cycles 1-3
Received Pembrolizumab (+) Berahyaluronidase Alfa SC
|
71
|
0
|
|
Treatment Crossover Period 1: Cycles 1-3
Received Pembrolizumab IV
|
0
|
76
|
|
Treatment Crossover Period 1: Cycles 1-3
COMPLETED
|
65
|
70
|
|
Treatment Crossover Period 1: Cycles 1-3
NOT COMPLETED
|
6
|
6
|
|
Treatment Crossover Period 2: Cycles 4-6
STARTED
|
65
|
70
|
|
Treatment Crossover Period 2: Cycles 4-6
Received Pembrolizumab (+) Berahyaluronidase Alfa SC
|
0
|
70
|
|
Treatment Crossover Period 2: Cycles 4-6
Received Pembrolizumab IV
|
65
|
0
|
|
Treatment Crossover Period 2: Cycles 4-6
COMPLETED
|
57
|
59
|
|
Treatment Crossover Period 2: Cycles 4-6
NOT COMPLETED
|
8
|
11
|
|
Treatment Continuation Period
STARTED
|
57
|
59
|
|
Treatment Continuation Period
COMPLETED
|
0
|
0
|
|
Treatment Continuation Period
NOT COMPLETED
|
57
|
59
|
Reasons for withdrawal
| Measure |
Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV
In Treatment Crossover Period 1 participants first received pembrolizumab plus berahyaluronidase alfa subcutaneously (SC) for three 21-day cycles, followed by pembrolizumab intravenously (IV) for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for renal cell carcinoma (RCC) and melanoma, and for up to 35 21-day cycles (up to \~2 years) for non-small cell lung cancer (NSCLC).
|
Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC
In Treatment Crossover Period 1 participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to \~2 years) for NSCLC.
|
|---|---|---|
|
Treatment Crossover Period 1: Cycles 1-3
Death
|
4
|
3
|
|
Treatment Crossover Period 1: Cycles 1-3
Ongoing
|
2
|
3
|
|
Treatment Crossover Period 2: Cycles 4-6
Death
|
2
|
3
|
|
Treatment Crossover Period 2: Cycles 4-6
Lost to Follow-up
|
1
|
0
|
|
Treatment Crossover Period 2: Cycles 4-6
Withdrawal by Subject
|
0
|
1
|
|
Treatment Crossover Period 2: Cycles 4-6
Ongoing
|
5
|
7
|
|
Treatment Continuation Period
Death
|
1
|
3
|
|
Treatment Continuation Period
Ongoing
|
56
|
56
|
Baseline Characteristics
A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)
Baseline characteristics by cohort
| Measure |
Arm A: Pembrolizumab (+) Berahyaluronidase Alfa SC →Pembrolizumab IV
n=71 Participants
In Treatment Crossover Period 1 participants first received pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to \~2 years) for NSCLC.
|
Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC
n=76 Participants
In Treatment Crossover Period 1 participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to \~2 years) for NSCLC.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
2 Participants
n=1054 Participants
|
|
Age, Continuous
|
59.7 Years
STANDARD_DEVIATION 11.8 • n=527 Participants
|
63.2 Years
STANDARD_DEVIATION 12.5 • n=527 Participants
|
61.5 Years
STANDARD_DEVIATION 12.3 • n=1054 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=527 Participants
|
28 Participants
n=527 Participants
|
57 Participants
n=1054 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=527 Participants
|
48 Participants
n=527 Participants
|
90 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=527 Participants
|
27 Participants
n=527 Participants
|
53 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=527 Participants
|
40 Participants
n=527 Participants
|
77 Participants
n=1054 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=527 Participants
|
9 Participants
n=527 Participants
|
17 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=527 Participants
|
5 Participants
n=527 Participants
|
8 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=527 Participants
|
0 Participants
n=527 Participants
|
0 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=527 Participants
|
2 Participants
n=527 Participants
|
2 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=527 Participants
|
60 Participants
n=527 Participants
|
118 Participants
n=1054 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=527 Participants
|
9 Participants
n=527 Participants
|
17 Participants
n=1054 Participants
|
PRIMARY outcome
Timeframe: Day 106Population: Per protocol, the analysis population (Full Analysis Set) included all randomized participants who received all three doses of pembrolizumab plus berahyaluronidase alfa SC and all three doses of pembrolizumab IV during the Treatment Crossover Period, and subsequently answered question 1 of the PPQ on Day 106.
The PPQ is an instrument that has been developed from participant interviews and includes questions to evaluate directly from participants their preference regarding mode of administration, as well as the strength of the preference, and the reason for the preference. The PPQ does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the PPQ evaluates participants' preferred method of administration with response options of IV, SC or "no preference". As pre-specified by the protocol, the percentage of participants who preferred SC administration (participant preference rate \[PPR\]) was reported out of all randomized participants who received all 3 doses of Pembrolizumab IV and Pembrolizumab SC during treatment crossover period and answered at least question 1 of the PPQ on Cycle 6 Day 1 (Day 106).
Outcome measures
| Measure |
Full Analysis Set
n=118 Participants
Randomized participants received three doses of pembrolizumab plus berahyaluronidase alfa SC and three doses of pembrolizumab IV during the Treatment Crossover Period and subsequently answered question 1 of the PPQ on Day 106.
|
Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC
In the Treatment Crossover Period participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles.
|
|---|---|---|
|
Percentage of Participants Who Prefer Pembrolizumab Plus Berahyaluronidase Alfa Subcutaneous (SC) As Assessed By Patient Preference Questionnaire (PPQ) Question 1
|
65.3 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Day 106Population: The analysis population included all randomized participants who received all three doses of pembrolizumab plus berahyaluronidase alfa SC and all three doses of pembrolizumab IV during the treatment crossover period, subsequently answered question 3 of the PPQ on Day 106, and preferred SC administration.
The PPQ is an instrument that has been developed from patient interviews and includes questions to evaluate directly from participants their preference regarding mode of administration, as well as the strength of the preference, and the reason for the preference. PPQ Question 3 evaluated 2 main reasons for participants' preference for one of the administration methods (SC or IV), with response options including "feels less emotionally distressing", "requires less time in the clinic", and "lower level injection-site pain". As pre-specified by the supplemental statistical analysis plan (sSAP), the most frequent reasons for preferring SC administration as assessed by PPQ Question 3 were reported among all participants preferring SC in each treatment arm. Treatment arms A (Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV) and B (Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC) were defined as treatment sequence arms in the protocol.
Outcome measures
| Measure |
Full Analysis Set
n=32 Participants
Randomized participants received three doses of pembrolizumab plus berahyaluronidase alfa SC and three doses of pembrolizumab IV during the Treatment Crossover Period and subsequently answered question 1 of the PPQ on Day 106.
|
Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC
n=45 Participants
In the Treatment Crossover Period participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles.
|
|---|---|---|
|
Percentage of Participants Who Preferred SC Administration According to Most Frequent Reasons of Preference As Assessed by PPQ Question 3
Requires less time in the clinic
|
59.4 Percentage of Participants
|
66.7 Percentage of Participants
|
|
Percentage of Participants Who Preferred SC Administration According to Most Frequent Reasons of Preference As Assessed by PPQ Question 3
Feels more comfortable during administration
|
68.8 Percentage of Participants
|
57.8 Percentage of Participants
|
|
Percentage of Participants Who Preferred SC Administration According to Most Frequent Reasons of Preference As Assessed by PPQ Question 3
Lower level of injection-site pain
|
31.3 Percentage of Participants
|
42.2 Percentage of Participants
|
|
Percentage of Participants Who Preferred SC Administration According to Most Frequent Reasons of Preference As Assessed by PPQ Question 3
Feels less emotionally distressing
|
21.9 Percentage of Participants
|
20.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to approximately Day 106Population: The analysis population included all randomized participants who received all three doses of pembrolizumab plus berahyaluronidase alfa SC and all three doses of pembrolizumab IV during the treatment crossover period, and subsequently answered question 1 of the TASQ SC.
The TASQ SC is a 12-item questionnaire that asks questions regarding different aspects of participants' satisfaction with SC administration, experiences related to administration, convenience, and time. The TASQ SC does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the TASQ SC evaluates participants' satisfaction or dissatisfaction with SC administration. As pre-specified by the sSAP, the percentage of participants was reported for each response to TASQ-SC Question 1 according to level of satisfaction, for each treatment arm. Treatment arms A (Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV) and B (Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC) were defined as treatment sequence arms in the protocol.
Outcome measures
| Measure |
Full Analysis Set
n=57 Participants
Randomized participants received three doses of pembrolizumab plus berahyaluronidase alfa SC and three doses of pembrolizumab IV during the Treatment Crossover Period and subsequently answered question 1 of the PPQ on Day 106.
|
Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC
n=61 Participants
In the Treatment Crossover Period participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles.
|
|---|---|---|
|
Percentage of Participants That Were Satisfied or Dissatisfied With the SC Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) Question 1
Very satisfied
|
71.9 Percentage of Participants
|
55.7 Percentage of Participants
|
|
Percentage of Participants That Were Satisfied or Dissatisfied With the SC Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) Question 1
Satisfied
|
26.3 Percentage of Participants
|
24.6 Percentage of Participants
|
|
Percentage of Participants That Were Satisfied or Dissatisfied With the SC Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) Question 1
Neither satisfied nor dissatisfied
|
0.0 Percentage of Participants
|
11.5 Percentage of Participants
|
|
Percentage of Participants That Were Satisfied or Dissatisfied With the SC Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) Question 1
Dissatisfied
|
1.8 Percentage of Participants
|
6.6 Percentage of Participants
|
|
Percentage of Participants That Were Satisfied or Dissatisfied With the SC Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) Question 1
Missing
|
0.0 Percentage of Participants
|
1.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to approximately Day 106Population: The analysis population included all randomized participants who received all three doses of pembrolizumab plus berahyaluronidase alfa SC and all three doses of pembrolizumab IV during the treatment crossover period, and subsequently answered question 1 of the TASQ IV.
The TASQ IV is a 12-item questionnaire that asks questions regarding different aspects of participants' satisfaction with IV administration, experiences related to administration, convenience, and time. The TASQ IV does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the TASQ IV evaluates participants' satisfaction or dissatisfaction with IV administration. As pre-specified by the sSAP, the percentage of participants was reported for each response to TASQ-IV Question 1 according to level of satisfaction, for each treatment arm. Treatment arms A (Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV) and B (Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC) were defined as treatment sequence arms in the protocol.
Outcome measures
| Measure |
Full Analysis Set
n=57 Participants
Randomized participants received three doses of pembrolizumab plus berahyaluronidase alfa SC and three doses of pembrolizumab IV during the Treatment Crossover Period and subsequently answered question 1 of the PPQ on Day 106.
|
Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC
n=61 Participants
In the Treatment Crossover Period participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles.
|
|---|---|---|
|
Percentage of Participants That Were Satisfied or Dissatisfied With the IV Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) Question 1
Very satisfied
|
45.6 Percentage of Participants
|
62.3 Percentage of Participants
|
|
Percentage of Participants That Were Satisfied or Dissatisfied With the IV Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) Question 1
Satisfied
|
33.3 Percentage of Participants
|
29.5 Percentage of Participants
|
|
Percentage of Participants That Were Satisfied or Dissatisfied With the IV Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) Question 1
Neither satisfied nor dissatisfied
|
17.5 Percentage of Participants
|
4.9 Percentage of Participants
|
|
Percentage of Participants That Were Satisfied or Dissatisfied With the IV Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) Question 1
Dissatisfied
|
1.8 Percentage of Participants
|
1.6 Percentage of Participants
|
|
Percentage of Participants That Were Satisfied or Dissatisfied With the IV Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) Question 1
Missing
|
1.8 Percentage of Participants
|
1.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 106Population: The analysis population included all randomized participants who chose to receive treatment intervention in the Treatment Continuation Period via the Participant Choice Questionnaire. Six participants included in the analysis chose to receive treatment in the Treatment Continuation Period but discontinued before receiving actual treatment.
The Participant Choice Questionnaire offered participants SC or IV treatment administration choices for the Treatment Continuation Period of the study, and was administered on Day 106 after study intervention administration. As pre-specified by the sSAP, the percentage of participants who chose either SC or IV treatment for the Treatment Continuation Period in the study was reported out of all randomized participants who chose to receive treatment intervention in the Treatment Continuation Period.
Outcome measures
| Measure |
Full Analysis Set
n=122 Participants
Randomized participants received three doses of pembrolizumab plus berahyaluronidase alfa SC and three doses of pembrolizumab IV during the Treatment Crossover Period and subsequently answered question 1 of the PPQ on Day 106.
|
Arm B: Pembrolizumab IV→Pembrolizumab (+) Berahyaluronidase Alfa SC
In the Treatment Crossover Period participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles.
|
|---|---|---|
|
Percentage of Participants Who Chose Pembrolizumab (+) Berahyaluronidase Alfa SC or Pembrolizumab IV for the Treatment Continuation Period on the Participant Choice Questionnaire
IV
|
32.0 Percentage of Participants
|
—
|
|
Percentage of Participants Who Chose Pembrolizumab (+) Berahyaluronidase Alfa SC or Pembrolizumab IV for the Treatment Continuation Period on the Participant Choice Questionnaire
SC
|
68.0 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Up to ~27 monthsAn AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified by the protocol, the number of participants who experience an AE will be reported for the overall study according to treatment arm, defined as a treatment sequence arm in the protocol (i.e., "Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV" and "Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC").
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to ~24 monthsAn AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified by the protocol, the number of participants who discontinue study drug due to an AE will be reported for the overall study according to treatment arm, defined as a treatment sequence arm in the protocol (i.e., "Pembrolizumab Plus Berahyaluronidase alfa SC followed by Pembrolizumab IV" and "Pembrolizumab IV followed by Pembrolizumab plus Berahyaluronidase alfa SC").
Outcome measures
Outcome data not reported
Adverse Events
Pembrolizumab (+) Berahyaluronidase Alfa SC
Serious events: 20 serious events
Other events: 99 other events
Deaths: 10 deaths
Pembrolizumab IV
Serious events: 22 serious events
Other events: 63 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Pembrolizumab (+) Berahyaluronidase Alfa SC
n=141 participants at risk
In Treatment Crossover Period 1 participants first received pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to \~2 years) for NSCLC.
|
Pembrolizumab IV
n=141 participants at risk
In Treatment Crossover Period 1 participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to \~2 years) for NSCLC.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Endocrine disorders
Hypophysitis
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
1.4%
2/141 • Number of events 2 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
General disorders
Asthenia
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
General disorders
Death
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Infections and infestations
Abscess
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Infections and infestations
Empyema
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
2.1%
3/141 • Number of events 3 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
2.8%
4/141 • Number of events 4 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Investigations
Lipase increased
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
4.3%
6/141 • Number of events 6 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
2.1%
3/141 • Number of events 3 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Nervous system disorders
Ischaemic stroke
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Nervous system disorders
Myasthenia gravis
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Psychiatric disorders
Bipolar disorder
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
1.4%
2/141 • Number of events 2 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
1.4%
2/141 • Number of events 2 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.71%
1/141 • Number of events 1 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
Other adverse events
| Measure |
Pembrolizumab (+) Berahyaluronidase Alfa SC
n=141 participants at risk
In Treatment Crossover Period 1 participants first received pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to \~2 years) for NSCLC.
|
Pembrolizumab IV
n=141 participants at risk
In Treatment Crossover Period 1 participants first received pembrolizumab IV for three 21-day cycles, followed by pembrolizumab plus berahyaluronidase alfa SC for three 21-day cycles in Treatment Crossover Period 2. After completion of the Treatment Crossover Period, participants entered the Treatment Continuation Period where they received their preferred intervention for up to 17 21-day cycles (up to \~1 year) for RCC and melanoma, and for up to 35 21-day cycles (up to \~2 years) for NSCLC.
|
|---|---|---|
|
General disorders
Fatigue
|
8.5%
12/141 • Number of events 12 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
5.7%
8/141 • Number of events 8 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
10/141 • Number of events 12 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
5.7%
8/141 • Number of events 8 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
14.2%
20/141 • Number of events 20 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
9.9%
14/141 • Number of events 16 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.9%
21/141 • Number of events 26 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
4.3%
6/141 • Number of events 8 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
General disorders
Asthenia
|
7.8%
11/141 • Number of events 14 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
5.0%
7/141 • Number of events 9 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
General disorders
Injection site pain
|
7.1%
10/141 • Number of events 10 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
General disorders
Injection site reaction
|
7.1%
10/141 • Number of events 15 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
0.00%
0/141 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
8/141 • Number of events 8 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
3.5%
5/141 • Number of events 5 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
7.8%
11/141 • Number of events 15 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
9.2%
13/141 • Number of events 16 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
10/141 • Number of events 13 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
7.1%
10/141 • Number of events 12 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
5.7%
8/141 • Number of events 8 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
4.3%
6/141 • Number of events 9 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
7/141 • Number of events 9 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
5.7%
8/141 • Number of events 8 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.5%
12/141 • Number of events 13 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
3.5%
5/141 • Number of events 5 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
8/141 • Number of events 9 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
5.0%
7/141 • Number of events 8 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.2%
20/141 • Number of events 24 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
6.4%
9/141 • Number of events 9 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.5%
12/141 • Number of events 14 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
2.8%
4/141 • Number of events 4 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
|
Vascular disorders
Hypertension
|
5.7%
8/141 • Number of events 9 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
1.4%
2/141 • Number of events 2 • Up to approximately 15 months
All-Cause Mortality was reported for all randomized participants by treatment received. Six participants did not receive both treatments but were evaluated for all-cause mortality. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not resulting in hospitalization or death were excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER