Trial Outcomes & Findings for A Study of TAK-659 in Combination With Bendamustine (+/-Rituximab), Gemcitabine, Lenalidomide, or Ibrutinib for the Treatment of Participants With Advanced Non-Hodgkin Lymphoma (NCT NCT02954406)

Last Updated: 2022-02-18

Results Overview

MTD was defined as the maximum dose that is determined to be safe and tolerable in different cohorts. Each cohort (A, B, C, D and E) received different escalating doses of TAK-659 in combination with other drugs. For each cohort the maximum tolerated dose of TAK-659 in combination with the other drug/s from the selected dose range is reported.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

43 participants

Primary outcome timeframe

Cycle 1 (Cohorts A, B and C - each cycle was of 21 days and Cohorts D and E - each cycle was of 28 days)

Results posted on

2022-02-18

Participant Flow

Participants took part in the study at 9 investigative sites in Canada, Spain, and the United States from 05 March 2017 to 27 July 2020. The study was planned to be conducted in two Phases: Dose Escalation Phase and Safety Expansion Phase, however, per Sponsor's decision, the study was terminated prior to enrollment of participants in the Safety Expansion Phase.

Participants with a diagnosis of advanced non-Hodgkin lymphoma were enrolled in Dose Escalation Phase Cohorts A, B, C, D and E of study to receive TAK-659 in combination with 1 of 5 combination drugs (bendamustine, bendamustine + rituximab, gemcitabine, lenalidomide, and ibrutinib) to determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D).

Participant milestones

Participant milestones
Measure	Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^2 TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced progressive disease (PD) or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^2 TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^2 TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
Overall Study STARTED	3	6	6	6	7	3	3	2	4	3
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	6	6	6	7	3	3	2	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^2 TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced progressive disease (PD) or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^2 TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^2 TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
Overall Study Adverse Event	0	1	0	0	1	0	0	0	1	1
Overall Study Progressive Disease	3	4	3	4	3	3	2	2	1	1
Overall Study Symptomatic Deterioration	0	1	0	0	0	0	0	0	0	0
Overall Study Death	0	0	0	0	1	0	0	0	1	1
Overall Study Reason Not Specified	0	0	3	2	2	0	1	0	1	0

Baseline Characteristics

Number analyzed is the number of participants with data available for height at the Baseline.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^2 n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^2 n=6 Participants TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^2 n=6 Participants TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=6 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=7 Participants TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=3 Participants TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg n=2 Participants TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg n=4 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.	Total n=43 Participants Total of all reporting groups
Age, Continuous	58.7 years n=3 Participants	61.8 years n=6 Participants	70.5 years n=6 Participants	61.3 years n=6 Participants	57.0 years n=7 Participants	72.7 years n=3 Participants	72.7 years n=3 Participants	58.5 years n=2 Participants	61.0 years n=4 Participants	71.0 years n=3 Participants	64.52 years n=43 Participants
Sex: Female, Male Female	2 Participants n=3 Participants	1 Participants n=6 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=7 Participants	1 Participants n=3 Participants	3 Participants n=3 Participants	0 Participants n=2 Participants	1 Participants n=4 Participants	1 Participants n=3 Participants	15 Participants n=43 Participants
Sex: Female, Male Male	1 Participants n=3 Participants	5 Participants n=6 Participants	3 Participants n=6 Participants	5 Participants n=6 Participants	5 Participants n=7 Participants	2 Participants n=3 Participants	0 Participants n=3 Participants	2 Participants n=2 Participants	3 Participants n=4 Participants	2 Participants n=3 Participants	28 Participants n=43 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=3 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	2 Participants n=43 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=3 Participants	5 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	5 Participants n=7 Participants	3 Participants n=3 Participants	3 Participants n=3 Participants	2 Participants n=2 Participants	4 Participants n=4 Participants	3 Participants n=3 Participants	40 Participants n=43 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	1 Participants n=43 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=43 Participants
Race (NIH/OMB) Asian	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	1 Participants n=43 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=43 Participants
Race (NIH/OMB) Black or African American	0 Participants n=3 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants	1 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	1 Participants n=3 Participants	3 Participants n=43 Participants
Race (NIH/OMB) White	3 Participants n=3 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants	5 Participants n=6 Participants	6 Participants n=7 Participants	3 Participants n=3 Participants	2 Participants n=3 Participants	2 Participants n=2 Participants	4 Participants n=4 Participants	2 Participants n=3 Participants	37 Participants n=43 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=43 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=7 Participants	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	2 Participants n=43 Participants
Region of Enrollment Spain	0 Participants n=3 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=7 Participants	1 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	4 Participants n=43 Participants
Region of Enrollment Canada	3 Participants n=3 Participants	4 Participants n=6 Participants	3 Participants n=6 Participants	5 Participants n=6 Participants	3 Participants n=7 Participants	2 Participants n=3 Participants	0 Participants n=3 Participants	2 Participants n=2 Participants	2 Participants n=4 Participants	2 Participants n=3 Participants	26 Participants n=43 Participants
Region of Enrollment United States	0 Participants n=3 Participants	2 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	3 Participants n=7 Participants	0 Participants n=3 Participants	3 Participants n=3 Participants	0 Participants n=2 Participants	2 Participants n=4 Participants	1 Participants n=3 Participants	13 Participants n=43 Participants
Height	171.5 cm n=2 Participants • Number analyzed is the number of participants with data available for height at the Baseline.	171.7 cm n=6 Participants • Number analyzed is the number of participants with data available for height at the Baseline.	163.0 cm n=6 Participants • Number analyzed is the number of participants with data available for height at the Baseline.	170.3 cm n=6 Participants • Number analyzed is the number of participants with data available for height at the Baseline.	172.7 cm n=7 Participants • Number analyzed is the number of participants with data available for height at the Baseline.	169.3 cm n=3 Participants • Number analyzed is the number of participants with data available for height at the Baseline.	154.3 cm n=3 Participants • Number analyzed is the number of participants with data available for height at the Baseline.	167.5 cm n=2 Participants • Number analyzed is the number of participants with data available for height at the Baseline.	169.8 cm n=4 Participants • Number analyzed is the number of participants with data available for height at the Baseline.	164.7 cm n=3 Participants • Number analyzed is the number of participants with data available for height at the Baseline.	167.5 cm n=42 Participants • Number analyzed is the number of participants with data available for height at the Baseline.
Weight	88.0 kg n=3 Participants	94.3 kg n=6 Participants	76.3 kg n=6 Participants	66.7 kg n=6 Participants	86.1 kg n=7 Participants	87.3 kg n=3 Participants	60.0 kg n=3 Participants	85.5 kg n=2 Participants	90.8 kg n=4 Participants	70.0 kg n=3 Participants	80.5 kg n=43 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Cohorts A, B and C - each cycle was of 21 days and Cohorts D and E - each cycle was of 28 days)

Population: Dose-limiting toxicity (DLT)-evaluable analysis set: participants who have met the minimum treatment and safety evaluation requirements of the study or who experience a DLT.

Outcome measures

Outcome measures
Measure	Dose Escalation Phase Cohort A: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 n=15 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort B: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=16 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40-60 mg + Lenalidomide 25 mg n=6 Participants TAK-659 40-60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.	Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
Dose Escalation Phase: Maximum Tolerated Dose (MTD) of TAK-659	NA mg Data was not available as MTD was not established.	NA mg Data was not available as MTD was not established.	NA mg Data was not available as MTD was not established.	NA mg Data was not available as MTD was not established.	NA mg Data was not available as MTD was not established.	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 (Cohorts A, B and C - each cycle was of 21 days and Cohorts D and E each cycle was of 28 days)

Population: DLT-evaluable analysis set: participants who have met the minimum treatment and safety evaluation requirements of the study or who experience a DLT.

The RP2D was the MTD or less. The dose recommended for use in phase 2 studies was analyzed on the basis of the safety, tolerability, and preliminary pharmacokinetic (PK) and efficacy data obtained in phase 1 studies. Each cohort (A, B, C, D and E) received different escalating doses of TAK-659 in combination with other drugs. For each cohort the recommended Phase 2 dose of TAK-659 in combination with the other drug/s from the selected dose range is reported.

Outcome measures

Outcome measures
Measure	Dose Escalation Phase Cohort A: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 n=15 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort B: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=16 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40-60 mg + Lenalidomide 25 mg n=6 Participants TAK-659 40-60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.	Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
Dose Escalation Phase: Recommended Phase 2 Dose (RP2D) of TAK-659	NA mg Data was not available as RP2D was not established.	60 mg	NA mg Data was not available as RP2D was not established.	NA mg Data was not available as RP2D was not established.	NA mg Data was not available as RP2D was not established.	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 1 and 15: Pre-dose and at multiple time points (up to 24 hours) post-dose in Cycle 1 (Cohorts A, B and C - each cycle was of 21 days and Cohorts D and E - each cycle was of 28 days)

Population: Pharmacokinetic (PK) Analysis Set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Number analyzed is the number of participants with data available for analyses at the given time point.

Outcome measures

Outcome measures
Measure	Dose Escalation Phase Cohort A: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 n=3 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort B: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=6 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=6 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40-60 mg + Lenalidomide 25 mg n=6 Participants TAK-659 40-60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=7 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.	Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=3 Participants TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg n=1 Participants TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg n=4 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
Cmax: Maximum Observed Plasma Concentration for TAK-659 Cycle 1 Day 1	83.61 nanograms(ng)/mL Geometric Coefficient of Variation 92.17	89.74 nanograms(ng)/mL Geometric Coefficient of Variation 59.03	118.10 nanograms(ng)/mL Geometric Coefficient of Variation 63.83	128.58 nanograms(ng)/mL Geometric Coefficient of Variation 27.19	142.84 nanograms(ng)/mL Geometric Coefficient of Variation 57.58	180.10 nanograms(ng)/mL Geometric Coefficient of Variation 17.93	141.27 nanograms(ng)/mL Geometric Coefficient of Variation 296.57	139.00 nanograms(ng)/mL Geometric Coefficient of Variation NA The geometric coefficient of variation was not estimable for 1 participant.	65.03 nanograms(ng)/mL Geometric Coefficient of Variation 80.98	120.23 nanograms(ng)/mL Geometric Coefficient of Variation 42.42
Cmax: Maximum Observed Plasma Concentration for TAK-659 Cycle 1 Day 15	126.49 nanograms(ng)/mL Geometric Coefficient of Variation 105.13	145.03 nanograms(ng)/mL Geometric Coefficient of Variation 96.78	187.73 nanograms(ng)/mL Geometric Coefficient of Variation 47.29	158.28 nanograms(ng)/mL Geometric Coefficient of Variation 43.71	222.96 nanograms(ng)/mL Geometric Coefficient of Variation 31.10	223.53 nanograms(ng)/mL Geometric Coefficient of Variation 44.02	303.34 nanograms(ng)/mL Geometric Coefficient of Variation 12.39	188.00 nanograms(ng)/mL Geometric Coefficient of Variation NA The geometric coefficient of variation was not estimable for 1 participant.	202.90 nanograms(ng)/mL Geometric Coefficient of Variation 69.27	306.59 nanograms(ng)/mL Geometric Coefficient of Variation 66.37

SECONDARY outcome

Timeframe: Days 1 and 15: Pre-dose and at multiple time points (up to 24 hours) post-dose in Cycle 1 (Cohorts A, B and C - each cycle was of 21 days and Cohorts D and E - each cycle was of 28 days)

Population: PK Analysis Set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Number analyzed is the number of participants with data available for analyses at the given time point.

Outcome measures

Outcome measures
Measure	Dose Escalation Phase Cohort A: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 n=3 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort B: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=6 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=6 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40-60 mg + Lenalidomide 25 mg n=6 Participants TAK-659 40-60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=7 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.	Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=3 Participants TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg n=1 Participants TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg n=4 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
Tmax: Time to Reach the Maximum Plasma Concentration for TAK-659 Cycle 1 Day 1	4.00 hours (h) Interval 4.0 to 4.0	2.03 hours (h) Interval 0.9 to 4.0	4.00 hours (h) Interval 2.1 to 7.7	1.10 hours (h) Interval 0.5 to 4.0	2.00 hours (h) Interval 0.5 to 4.0	2.00 hours (h) Interval 0.1 to 4.0	4.13 hours (h) Interval 0.7 to 4.2	0.6 hours (h) Interval 0.6 to 0.6	2.12 hours (h) Interval 0.7 to 4.0	1.00 hours (h) Interval 0.5 to 2.0
Tmax: Time to Reach the Maximum Plasma Concentration for TAK-659 Cycle 1 Day 15	4.00 hours (h) Interval 2.0 to 4.1	1.09 hours (h) Interval 0.3 to 4.5	3.83 hours (h) Interval 0.9 to 7.5	1.17 hours (h) Interval 1.0 to 4.0	1.93 hours (h) Interval 0.8 to 4.0	2.47 hours (h) Interval 0.9 to 4.0	2.76 hours (h) Interval 1.0 to 4.5	1.9 hours (h) Interval 1.9 to 1.9	2.08 hours (h) Interval 0.5 to 8.0	1.01 hours (h) Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Days 1 and 15: Pre-dose and at multiple time points (up to 24 hours) post-dose in Cycle 1 (Cohorts A, B and C - each cycle was of 21 days and Cohorts D and E - each cycle was of 28 days)

Outcome measures

Outcome measures
Measure	Dose Escalation Phase Cohort A: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 n=3 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort B: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=6 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=6 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40-60 mg + Lenalidomide 25 mg n=6 Participants TAK-659 40-60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=7 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.	Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=3 Participants TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg n=1 Participants TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg n=4 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
AUCtau: Area Under the Plasma Concentration-time Curve During Dosing Interval Cycle 1 Day 1	1094.51 h×ng/mL Geometric Coefficient of Variation 52.35	1011.49 h×ng/mL Geometric Coefficient of Variation 53.85	1532.34 h×ng/mL Geometric Coefficient of Variation 65.52	852.36 h×ng/mL Geometric Coefficient of Variation 40.94	1455.92 h×ng/mL Geometric Coefficient of Variation 44.57	1444.89 h×ng/mL Geometric Coefficient of Variation 19.43	387.54 h×ng/mL Geometric Coefficient of Variation NA The geometric coefficient of variation was not estimable for 1 participant.	1456.03 h×ng/mL Geometric Coefficient of Variation NA The geometric coefficient of variation was not estimable for 1 participant.	758.76 h×ng/mL Geometric Coefficient of Variation 76.63	968.82 h×ng/mL Geometric Coefficient of Variation 36.59
AUCtau: Area Under the Plasma Concentration-time Curve During Dosing Interval Cycle 1 Day 15	1845.21 h×ng/mL Geometric Coefficient of Variation 74.17	1675.91 h×ng/mL Geometric Coefficient of Variation 90.89	3050.97 h×ng/mL Geometric Coefficient of Variation 54.46	1896.76 h×ng/mL Geometric Coefficient of Variation 43.15	2788.61 h×ng/mL Geometric Coefficient of Variation 17.61	2662.16 h×ng/mL Geometric Coefficient of Variation 21.31	3251.29 h×ng/mL Geometric Coefficient of Variation NA The geometric coefficient of variation was not estimable for 1 participant.	2536.48 h×ng/mL Geometric Coefficient of Variation NA The geometric coefficient of variation was not estimable for 1 participant.	2578.30 h×ng/mL Geometric Coefficient of Variation 24.56	4218.90 h×ng/mL Geometric Coefficient of Variation 46.77

SECONDARY outcome

Timeframe: Up to 123 weeks

Population: Response-evaluable Analysis Set included participants who received at least 1 dose of study drug, had sites of measurable disease at Baseline, and 1 post-baseline disease assessment.

ORR was defined as the percentage of participants in the response-evaluable population who achieved either complete response (CR), or partial response (PR). CR was defined as the disappearance of all evidence of disease, and PR was defined as regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Dose Escalation Phase Cohort A: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 n=3 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort B: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=4 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=6 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40-60 mg + Lenalidomide 25 mg n=5 Participants TAK-659 40-60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=5 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.	Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=3 Participants TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=2 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg n=1 Participants TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=2 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
Overall Response Rate (ORR)	33.3 percentage of participants	75.0 percentage of participants	50.0 percentage of participants	40.0 percentage of participants	80.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	100.0 percentage of participants	33.3 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 123 weeks

Population: Response-evaluable Analysis Set included participants who received at least 1 dose of study drug, had sites of measurable disease at Baseline, and 1 post-baseline disease assessment. Only responders were analyzed for this outcome measure.

DOR was defined as the time from the date of first documented response to the date of first documented PD. PD was defined as any new lesion or increase by \> 50% of previously involved sites from nadir.

Outcome measures

Outcome measures
Measure	Dose Escalation Phase Cohort A: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 n=1 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort B: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=3 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40-60 mg + Lenalidomide 25 mg n=2 Participants TAK-659 40-60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=4 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.	Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg n=1 Participants TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg n=1 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=1 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
Duration of Response (DOR)	2.3 months Due to low number of participants with events upper and lower limits of 95% confidence interval (CI) were not estimable.	2.8 months Interval 1.2 to 4.3	NA months Interval 1.4 to Median, and upper limits of 95% CI were not estimable as participants were censored.	NA months Due to low number of participants with events Median, upper and lower limits of 95% CI were not estimable.	3.9 months Interval 2.9 to 4.8	—	—	1.8 months Due to low number of participants with events upper and lower limits of 95% CI were not estimable.	NA months Due to low number of participants with events median, upper and lower limits of 95% CI were not estimable.	NA months Median, upper and lower limits of 95% CI were not estimable as participants were censored.

SECONDARY outcome

Timeframe: Up to 123 weeks

Population: Response-evaluable Analysis Set included participants who received at least 1 dose of study drug, had sites of measurable disease at Baseline, and 1 post-baseline disease assessment.

TTP was defined as the time from the date of first drug administration to the date of first documented PD. PD was defined as any new lesion or increase by \>50% of previously involved sites from nadir.

Outcome measures

Outcome measures
Measure	Dose Escalation Phase Cohort A: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 n=3 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort B: TAK-659 60-100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=4 Participants TAK-659 60-100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=6 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40-60 mg + Lenalidomide 25 mg n=5 Participants TAK-659 40-60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=5 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.	Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=3 Participants TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=2 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg n=1 Participants TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg n=3 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=2 Participants TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.
Time to Progression (TTP)	4.2 months Interval 1.3 to 4.7	2.7 months Interval 2.5 to 5.6	9.6 months Interval 4.4 to Due to low number of participants with events the upper limit of 95% CI was not estimable.	2.6 months Interval 1.3 to Due to low number of participants with events the upper limit of 95% CI was not estimable.	4.2 months Interval 3.8 to 8.3	1.3 months Interval 0.6 to 1.5	1.4 months Interval 1.3 to 1.5	3.4 months Due to low number of participants with events upper and lower limits of 95% CI were not estimable.	NA months Interval 0.7 to Due to low number of participants with events the median, and upper limit of 95% CI were not estimable.	2.7 months Due to low number of participants with events upper and lower limits of 95% CI were not estimable.

SECONDARY outcome

Timeframe: Up to study completion (Up to 123 weeks)

Population: Data is not available for this outcome measure as the study was terminated prior to start of safety expansion phase.

PFS was defined as the time from the date of first study drug administration to the date of first documented PD or death due to any cause, whichever occurs first. PD was defined as any new lesion or increase by \>50% of previously involved sites from nadir.

Outcome measures

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=3 participants at risk TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=3 participants at risk TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg n=2 participants at risk TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg n=4 participants at risk TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=3 participants at risk TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.	Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^2 n=3 participants at risk TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^2 n=6 participants at risk TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^2 n=6 participants at risk TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=6 participants at risk TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=7 participants at risk TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
Infections and infestations Aspergillus infection	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Infections and infestations Cellulitis	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Infections and infestations Cytomegalovirus infection reactivation	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Infections and infestations Influenza	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Infections and infestations Neutropenic sepsis	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 1/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Nervous system disorders Spinal cord compression	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Nervous system disorders Headache	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Vascular disorders Hypotension	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Colitis	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Neutropenic colitis	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
General disorders Pyrexia	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
General disorders Asthenia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
General disorders Sudden death	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Immune system disorders Cytokine release syndrome	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Cardiac disorders Cardiac disorder	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Dose Escalation Phase Cohort B: TAK-659 100 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=3 participants at risk TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort C: TAK-659 60 mg + Gemcitabine 1000 mg/m^2 n=3 participants at risk TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with gemcitabine 1000 mg/m\^2, infusion, intravenously, over 30 minutes on Days 1 and 8 in a 21-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 2 cycles.	Dose Escalation Phase Cohort D: TAK-659 40 mg + Lenalidomide 25 mg n=2 participants at risk TAK-659 40 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. The TAK-659 60 mg dose was de-escalated to 40 mg in case of dose limiting toxicity or if the starting dose was determined to be not tolerable. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort D: TAK-659 60 mg + Lenalidomide 25 mg n=4 participants at risk TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 28 along with lenalidomide 25 mg, capsules orally, once daily on Days 1 to 21 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 26 cycles.	Dose Escalation Phase Cohort E: TAK-659 60 mg + Ibrutinib 560 mg n=3 participants at risk TAK-659 60 mg, immediate-release tablet, orally, once daily along with ibrutinib 560 mg capsules, orally, once daily on Days 1 to 28 in a 28-day treatment cycle. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 3 cycles.	Dose Escalation Phase Cohort A: TAK-659 60 mg + Bendamustine 90 mg/m^2 n=3 participants at risk TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort A: TAK-659 80 mg + Bendamustine 90 mg/m^2 n=6 participants at risk TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort A: TAK-659 100 mg + Bendamustine 90 mg/m^2 n=6 participants at risk TAK-659 100 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 100 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 39 cycles.	Dose Escalation Phase Cohort B: TAK-659 60 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=6 participants at risk TAK-659 60 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.	Dose Escalation Phase Cohort B: TAK-659 80 mg + Bendamustine 90 mg/m^2 + Rituximab 375 mg/m^2 n=7 participants at risk TAK-659 80 mg, immediate-release tablet, orally, once daily on Days 1 to 21 along with bendamustine 90 mg/m\^2, infusion, intravenously, over 10 or 60 minutes on Days 1 and 2 along with rituximab 375 mg/m\^2, infusion, intravenously, on Day 1 in a 21-day treatment cycle, for up to 8 cycles. The TAK-659 was escalated to 80 mg once daily after safety and tolerability of 60 mg dose was determined. Participants continued to receive TAK-659 monotherapy until they experienced PD or unacceptable toxicities or up to 12 cycles.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 1/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 2/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 3/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	100.0% 2/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 2/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 4/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	83.3% 5/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	75.0% 3/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	83.3% 5/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	42.9% 3/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 1/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 2/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 3/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 3/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 3/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 2/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	100.0% 3/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 3/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 4/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 4/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 3/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
General disorders Pyrexia	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	100.0% 3/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 3/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 3/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 3/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	71.4% 5/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
General disorders Oedema peripheral	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
General disorders Asthenia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	42.9% 3/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
General disorders Chills	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	42.9% 3/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
General disorders Peripheral swelling	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
General disorders Swelling face	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	100.0% 6/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	71.4% 5/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Investigations Amylase increased	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	100.0% 3/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 3/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	42.9% 3/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 3/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 3/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	42.9% 3/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Investigations Lipase increased	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 3/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	57.1% 4/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Investigations White blood cell count decreased	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	100.0% 3/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Investigations Platelet count decreased	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Investigations Lymphocyte count decreased	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 2/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Investigations Neutrophil count decreased	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	100.0% 3/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 3/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	57.1% 4/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	83.3% 5/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	42.9% 3/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 1/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 1/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Infections and infestations Cytomegalovirus infection reactivation	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Infections and infestations Skin infection	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Infections and infestations Oral candidiasis	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	42.9% 3/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Infections and infestations Oral herpes	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 1/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	66.7% 2/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Nervous system disorders Headache	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Nervous system disorders Dysgeusia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	28.6% 2/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	14.3% 1/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Eye disorders Periorbital oedema	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	50.0% 2/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Vascular disorders Hypertension	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 1/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	16.7% 1/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/2 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	25.0% 1/4 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/3 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	33.3% 2/6 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.	0.00% 0/7 • From signing of the informed consent form (ICF) through 28 days after the last dose (Up to 123 weeks) of study drug or to the start of subsequent anticancer therapy, whichever occurs first Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included participants who have received at least 1 dose of study drug.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Publication restrictions are in place

Restriction type: OTHER