Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Hematologic Malignancies (MK-3475-155/KEYNOTE-155) (NCT NCT02684617)

Last Updated: 2021-03-01

Results Overview

DLTs consisted of the following if observed during treatment Cycles 1 or 2 and assessed by investigator to be possibly, probably, or definitely related to pembrolizumab or dinaciclib: grade 4 non-laboratory nonhematologic toxicity; grade 4 hematologic toxicity lasting \>7 days (except thrombocytopenia); grade 4 thrombocytopenia of any duration; grade 3 thrombocytopenia if associated with bleeding; any grade 3 non-laboratory nonhematologic toxicity, except grade 3 nausea, vomiting, or diarrhea, which was not considered a DLT unless lasting more than 3 days despite optimal supportive care; Grade 3 or Grade 4 nonhematologic laboratory abnormality that required medical intervention, led to hospitalization, or persisted for \>1 week; grade 3 or 4 febrile neutropenia; any drug-related AE that caused participant to discontinue treatment during Cycles 1 or 2; grade 5 toxicity; treatment-related toxicity that caused a \>2-week delay in initiation of treatment Cycle 2 or 3. Each cycle was 21 days.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

75 participants

Primary outcome timeframe

Up to 42 days

Results posted on

2021-03-01

Participant Flow

The rrMM Cohort was closed to enrollment on 07-AUG-2017 due to lack of efficacy. The rrCLL Cohort was closed to enrollment on 30-APR-2019 due to lack of efficacy.

Participant milestones

Participant milestones
Measure	rrCLL Cohort Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrMM Cohort Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrDLBCL Cohort Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
Overall Study STARTED	18	17	40
Overall Study Treated	17	17	38
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	18	17	40

Reasons for withdrawal

Reasons for withdrawal
Measure	rrCLL Cohort Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrMM Cohort Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrDLBCL Cohort Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
Overall Study Adverse Event	1	0	1
Overall Study Death	8	16	28
Overall Study Withdrawal by Subject	2	0	4
Overall Study Screen Failure	1	0	2
Overall Study Study Terminated by Sponsor	6	1	5

Baseline Characteristics

Study of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Hematologic Malignancies (MK-3475-155/KEYNOTE-155)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rrCLL Cohort n=17 Participants Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrMM Cohort n=17 Participants Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrDLBCL Cohort n=38 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	Total n=72 Participants Total of all reporting groups
Age, Continuous	68.1 Years STANDARD_DEVIATION 10.9 • n=99 Participants	60.8 Years STANDARD_DEVIATION 9.5 • n=107 Participants	64.1 Years STANDARD_DEVIATION 11.1 • n=206 Participants	64.3 Years STANDARD_DEVIATION 10.9 • n=7 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	11 Participants n=107 Participants	15 Participants n=206 Participants	29 Participants n=7 Participants
Sex: Female, Male Male	14 Participants n=99 Participants	6 Participants n=107 Participants	23 Participants n=206 Participants	43 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants	5 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=99 Participants	16 Participants n=107 Participants	34 Participants n=206 Participants	67 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	4 Participants n=206 Participants	4 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	3 Participants n=107 Participants	2 Participants n=206 Participants	6 Participants n=7 Participants
Race (NIH/OMB) White	16 Participants n=99 Participants	14 Participants n=107 Participants	32 Participants n=206 Participants	62 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants

PRIMARY outcome

Timeframe: Up to 42 days

Population: The analysis population included all participants who received ≥1 dose of study medication, and who did not discontinue within the first two 21-day cycles of treatment or who experienced a DLT prior to completing the first two cycles of treatment.

Outcome measures

Outcome measures
Measure	rrCLL Cohort n=3 Participants Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrMM Cohort n=3 Participants Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrDLBCL Cohort n=6 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
Number of Participants With Dose Limiting Toxicity (DLT)	1 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to approximately 582 days

Population: The analysis population included all participants who received ≥1 dose of study treatment.

An adverse event (AE) was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE was presented.

Outcome measures

Outcome measures
Measure	rrCLL Cohort n=17 Participants Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrMM Cohort n=17 Participants Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrDLBCL Cohort n=38 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
Number of Participants Who Experienced an Adverse Event	17 Participants	16 Participants	37 Participants

PRIMARY outcome

Timeframe: Up to 492 days

Population: The analysis population included all participants who received ≥1 dose of study treatment.

An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study drug due to an adverse event is presented.

Outcome measures

Outcome measures
Measure	rrCLL Cohort n=17 Participants Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrMM Cohort n=17 Participants Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrDLBCL Cohort n=38 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
Number of Participants Who Discontinued Treatment Due to an Adverse Event	4 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 26 months

Population: The analysis population included all participants who received ≥1 dose of study treatment.

ORR is defined in participants with CLL as the percentage of participants who have a confirmed Complete Response (CR) or Partial Response (PR) per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines (2008) as assessed by the investigator; in participants with DLBCL as the above definition but per the Revised Response Criteria for Malignant Lymphoma (2007) as assessed by the investigator; and in participants with MM as the percentage of participants who have a confirmed Stringent Complete Response (sCR), CR, PR, or Very Good Partial Remission (VGPR) per the International Uniform Response Criteria for Multiple Myeloma (2006) as assessed by the investigator.

Outcome measures

Outcome measures
Measure	rrCLL Cohort n=17 Participants Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrMM Cohort n=17 Participants Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrDLBCL Cohort n=38 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
Objective Response Rate (ORR)	29.4 Percentage of Participants Interval 10.3 to 56.0	0.0 Percentage of Participants Interval 0.0 to 19.5	21.1 Percentage of Participants Interval 9.6 to 37.3

SECONDARY outcome

Timeframe: Up to approximately 26 months

Population: The analysis population included all participants who received ≥1 dose of study treatment and experienced a response to study treatment.

DOR is the time from initial response to Progressive Disease (PD) or death, whichever occurred first. A response was: in participants with CLL, a confirmed Complete Response (CR) or Partial Response (PR) per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines (2008); in participants with DLBCL, as above but per the Revised Response Criteria for Malignant Lymphoma (2007); and in participants with MM, a confirmed Stringent Complete Response (sCR), CR, PR, or Very Good Partial Remission (VGPR) per the International Uniform Response Criteria for Multiple Myeloma (2006). The above guidelines also define PD by disease. Assessments were by investigator. Data were censored at last disease assessment documenting absence of PD for participants who: had no PD and were still on the trial; received antitumor treatment other than that of the trial; or were removed from trial prior to PD. DOR was analyzed using the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	rrCLL Cohort n=5 Participants Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrMM Cohort Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrDLBCL Cohort n=8 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
Duration of Response (DOR)	NA Months Interval to 11.1 NA=Median DOR/DOR lower limit not reached	—	4.9 Months Interval 2.1 to NA=DOR upper limit not reached

SECONDARY outcome

Timeframe: Up to approximately 26 months

Population: The analysis population included all participants who received ≥1 dose of study treatment.

PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD evaluations were done based on the cancer-specific criteria of: the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines (2008) in participants with CLL; the Revised Response Criteria for Malignant Lymphoma (2007) in participants with DLBCL; and the International Uniform Response Criteria for Multiple Myeloma (2006) in participants with MM. Assessments were by investigator. PFS data were censored for participants with no PD or death at their last disease assessment, or at their last disease assessment prior to starting new anticancer treatment for those who did so. PFS was analyzed using the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	rrCLL Cohort n=17 Participants Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrMM Cohort n=17 Participants Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrDLBCL Cohort n=38 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
Progression-Free Survival (PFS)	5.2 Months Interval 1.4 to 12.4	1.6 Months Interval 0.7 to 2.8	2.1 Months Interval 1.8 to 2.6

SECONDARY outcome

Timeframe: Up to approximately 44 months

Population: The analysis population included all participants who received ≥1 dose of study treatment.

OS was defined as the time from first dose of study treatment to death due to any cause. Data were censored at the date of a participant's last follow-up. OS was analyzed using the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	rrCLL Cohort n=17 Participants Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrMM Cohort n=17 Participants Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrDLBCL Cohort n=38 Participants Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
Overall Survival (OS)	21.7 Months Interval 9.5 to NA=OS upper limit not reached	10.5 Months Interval 2.6 to 13.5	7.9 Months Interval 3.2 to 14.0

Adverse Events

rrCLL Cohort

Serious events: 13 serious events

Other events: 17 other events

Deaths: 9 deaths

rrMM Cohort

Serious events: 6 serious events

Other events: 16 other events

Deaths: 16 deaths

rrDLBCL Cohort

Serious events: 17 serious events

Other events: 37 other events

Deaths: 32 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	rrCLL Cohort n=17 participants at risk Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrMM Cohort n=17 participants at risk Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrDLBCL Cohort n=38 participants at risk Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
Blood and lymphatic system disorders Anaemia	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Febrile neutropenia	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Thrombocytopenia	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Cardiac disorders Atrial fibrillation	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Cardiac disorders Coronary artery disease	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Ear and labyrinth disorders Vertigo positional	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Duodenal ulcer haemorrhage	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
General disorders Chills	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
General disorders Death	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
General disorders Drug withdrawal syndrome	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
General disorders Pyrexia	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
General disorders Systemic inflammatory response syndrome	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Immune system disorders Cytokine release syndrome	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Infections and infestations Bronchitis viral	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Infections and infestations Disseminated tuberculosis	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Infections and infestations Osteomyelitis	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Infections and infestations Perirectal abscess	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Infections and infestations Pneumonia	11.8% 2/17 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Infections and infestations Pulmonary sepsis	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Infections and infestations Sepsis	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.3% 2/38 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Femur fracture	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Vascular access complication	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Wound	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Investigations Blood creatinine increased	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Decreased appetite	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Dehydration	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyperglycaemia	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyperkalaemia	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Tumour lysis syndrome	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.3% 2/38 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Muscular weakness	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.3% 2/38 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Nervous system disorders Loss of consciousness	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.

Other adverse events
Measure	rrCLL Cohort n=17 participants at risk Participants with refractory chronic lymphocytic leukemia (rrCLL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrMM Cohort n=17 participants at risk Participants with relapsed or refractory multiple myeloma (rrMM) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.	rrDLBCL Cohort n=38 participants at risk Participants with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 7 mg/m\^2 on Cycle 1 Day 1, and infusion of dinaciclib 10 mg/m\^2 alone on Cycle 1 Day 8. Participants then received an infusion of pembrolizumab 200 mg followed by infusion of dinaciclib 14 mg/m\^2 on Cycles 2-35 Day 1 and infusion of dinaciclib 14 mg/m\^2 alone on Cycles 2-35 Day 8. Each cycle is 21 days.
General disorders Early satiety	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Anaemia	41.2% 7/17 • Number of events 8 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	35.3% 6/17 • Number of events 6 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	15.8% 6/38 • Number of events 9 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Haemorrhagic diathesis	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Increased tendency to bruise	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Leukocytosis	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Neutropenia	29.4% 5/17 • Number of events 13 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	11.8% 2/17 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	10.5% 4/38 • Number of events 8 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Thrombocytopenia	11.8% 2/17 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.3% 2/38 • Number of events 3 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Cardiac disorders Angina pectoris	5.9% 1/17 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Cardiac disorders Atrial fibrillation	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Cardiac disorders Palpitations	5.9% 1/17 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Cardiac disorders Sinus tachycardia	5.9% 1/17 • Number of events 3 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Ear and labyrinth disorders Deafness	11.8% 2/17 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Ear and labyrinth disorders Ear pain	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Ear and labyrinth disorders Vertigo	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Endocrine disorders Hypothyroidism	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Eye disorders Vision blurred	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal discomfort	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	7.9% 3/38 • Number of events 3 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal distension	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.3% 2/38 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	15.8% 6/38 • Number of events 7 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain lower	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	7.9% 3/38 • Number of events 3 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Constipation	17.6% 3/17 • Number of events 3 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	17.6% 3/17 • Number of events 3 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	36.8% 14/38 • Number of events 19 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Diarrhoea	17.6% 3/17 • Number of events 3 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	17.6% 3/17 • Number of events 3 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	26.3% 10/38 • Number of events 17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Dry mouth	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.3% 2/38 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gastritis	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gastrooesophageal reflux disease	11.8% 2/17 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Mouth ulceration	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.3% 2/38 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Nausea	41.2% 7/17 • Number of events 10 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	23.5% 4/17 • Number of events 4 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	39.5% 15/38 • Number of events 18 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Post-tussive vomiting	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Retching	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Stomatitis	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	7.9% 3/38 • Number of events 3 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Toothache	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
Gastrointestinal disorders Vomiting	11.8% 2/17 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	11.8% 2/17 • Number of events 3 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	10.5% 4/38 • Number of events 5 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
General disorders Asthenia	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	11.8% 2/17 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
General disorders Axillary pain	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
General disorders Catheter site erythema	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 2 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
General disorders Catheter site pain	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/38 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
General disorders Chest pain	5.9% 1/17 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	2.6% 1/38 • Number of events 1 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
General disorders Chills	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	0.00% 0/17 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	7.9% 3/38 • Number of events 3 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.
General disorders Fatigue	64.7% 11/17 • Number of events 12 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	35.3% 6/17 • Number of events 7 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.	31.6% 12/38 • Number of events 15 • Up to approximately 522 days for non-serious adverse events. Up to approximately 582 days for serious adverse events. Up to approximately 610 days for all-cause mortality. MedDRA preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to the drug are excluded.