Trial Outcomes & Findings for Phase 1/2 Study of BBT-176 in Advanced NSCLC With Progression After EGFR TKI Treatment (NCT NCT04820023)

NCT ID: NCT04820023

Last Updated: 2025-06-06

Results Overview

Any toxicity not attributable to the disease or disease-related processes under investigation that occurs from the first dose of study treatment in dose-escalation cohorts as defined in the protocol.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

45 participants

Primary outcome timeframe

21 days from the first dosing

Results posted on

2025-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	20mg QD BBT-176: 20mg, Orally, QD	80mg QD BBT-176: 80mg, Orally, QD	160mg, QD BBT-176: 160mg, Orally, QD	320mg, QD BBT-176: 320mg, Orally, QD	480mg, QD BBT-176: 480mg, Orally, QD	600mg, QD BBT-176: 600mg, Orally, QD	160mg, BID BBT-176: 160mg, Orally, BID	200mg, BID BBT-176: 200mg, Orally, BID	240mg, BID BBT-176: 240mg, Orally, BID
Overall Study STARTED	4	3	4	3	8	3	5	9	6
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	4	3	4	3	8	3	5	9	6

Reasons for withdrawal

Reasons for withdrawal
Measure	20mg QD BBT-176: 20mg, Orally, QD	80mg QD BBT-176: 80mg, Orally, QD	160mg, QD BBT-176: 160mg, Orally, QD	320mg, QD BBT-176: 320mg, Orally, QD	480mg, QD BBT-176: 480mg, Orally, QD	600mg, QD BBT-176: 600mg, Orally, QD	160mg, BID BBT-176: 160mg, Orally, BID	200mg, BID BBT-176: 200mg, Orally, BID	240mg, BID BBT-176: 240mg, Orally, BID
Overall Study Death	0	0	0	0	0	0	1	0	1
Overall Study Withdrawal by Subject	1	2	2	1	4	3	3	6	5
Overall Study Progressive Disease	3	0	2	2	2	0	1	1	0
Overall Study New anti-cancer therapy	0	0	0	0	2	0	0	0	0
Overall Study Other	0	1	0	0	0	0	0	2	0

Baseline Characteristics

Phase 1/2 Study of BBT-176 in Advanced NSCLC With Progression After EGFR TKI Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	20mg QD n=4 Participants BBT-176: 20mg, Orally, QD	80mg QD n=3 Participants BBT-176: 80mg, Orally, QD	160mg QD n=4 Participants BBT-176: 160mg, Orally, QD	320mg QD n=3 Participants BBT-176: 320mg, Orally, QD	480mg QD n=8 Participants BBT-176: 480mg, Orally, QD	600mg QD n=3 Participants BBT-176: 600mg, Orally, QD	160mg BID n=5 Participants BBT-176: 160mg, Orally, BID	200mg BID n=9 Participants BBT-176: 200mg, Orally, BID	240mg BID n=6 Participants BBT-176: 240mg, Orally, BID	Total n=45 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 6.5 • n=99 Participants	62.3 years STANDARD_DEVIATION 11.9 • n=107 Participants	48.0 years STANDARD_DEVIATION 9.1 • n=206 Participants	50.0 years STANDARD_DEVIATION 10.1 • n=7 Participants	63.9 years STANDARD_DEVIATION 10.1 • n=31 Participants	73.0 years STANDARD_DEVIATION 5.3 • n=30 Participants	63.2 years STANDARD_DEVIATION 9.4 • n=3 Participants	62.3 years STANDARD_DEVIATION 10.5 • n=6 Participants	65.5 years STANDARD_DEVIATION 7.1 • n=114 Participants	62.1 years STANDARD_DEVIATION 10.5
Sex: Female, Male Female	3 Participants n=99 Participants	3 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants	6 Participants n=31 Participants	2 Participants n=30 Participants	2 Participants n=3 Participants	7 Participants n=6 Participants	5 Participants n=114 Participants	31 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants	1 Participants n=7 Participants	2 Participants n=31 Participants	1 Participants n=30 Participants	3 Participants n=3 Participants	2 Participants n=6 Participants	1 Participants n=114 Participants	14 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants	3 Participants n=7 Participants	8 Participants n=31 Participants	3 Participants n=30 Participants	5 Participants n=3 Participants	9 Participants n=6 Participants	6 Participants n=114 Participants	45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants

PRIMARY outcome

Timeframe: 21 days from the first dosing

Any toxicity not attributable to the disease or disease-related processes under investigation that occurs from the first dose of study treatment in dose-escalation cohorts as defined in the protocol.

Outcome measures

Outcome measures
Measure	20mg QD n=4 Participants BBT-176: 20mg, Orally, QD	80mg QD n=3 Participants BBT-176: 80mg, Orally, QD	160mg, QD n=4 Participants BBT-176: 160mg, Orally, QD	320mg, QD n=3 Participants BBT-176: 320mg, Orally, QD	480mg, QD n=8 Participants BBT-176: 480mg, Orally, QD	600mg, QD n=3 Participants BBT-176: 600mg, Orally, QD	160mg, BID n=5 Participants BBT-176: 160mg, Orally, BID	200mg, BID n=9 Participants BBT-176: 200mg, Orally, BID	240mg, BID n=6 Participants BBT-176: 240mg, Orally, BID	480mg QD C2D1 BBT-176: 480mg QD C2D1	600mg QD C1D1 BBT-176: 600mg QD C1D1 \- PK samples were collected at 600 mg QD, but drug exposure was low due to vomiting, making it impossible to determine PK parameters.	600mg QD C2D1 BBT-176: 600mg QD C2D1 \- PK samples were collected at 600 mg QD, but drug exposure was low due to vomiting, making it impossible to determine PK parameters.	160mg BID C1D1 BBT-176: 160mg BID C1D1	160mg BID C2D1 BBT-176: 160mg BID C2D1	200mg BID C1D1 BBT-176: 200mg BID C1D1	200mg BID C2D1 BBT-176: 200mg BID C2D1	240mg BID C1D1 BBT-176: 240mg BID C1D1	240mg BID C2D1 BBT-176: 240mg BID C2D1
(Part 1) Incidence of Adverse Events and Clinical Laboratory Abnormalities Defined as Dose-limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Every 6 weeks

Population: Due to early termination of the study, Part 2 and analysis was not conducted.

ORR is estimated by the number of patients with a best overall response of CR or PR divided by the total number of patients who are evaluable for efficacy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 6 weeks, approximately 1 year

ORR is estimated by the number of patients with a best overall response of Complete Response (CR) or Partial Response (PR) divided by the total number of patients who are evaluable for efficacy.

Outcome measures

Outcome measures
Measure	20mg QD n=4 Participants BBT-176: 20mg, Orally, QD	80mg QD n=3 Participants BBT-176: 80mg, Orally, QD	160mg, QD n=4 Participants BBT-176: 160mg, Orally, QD	320mg, QD n=3 Participants BBT-176: 320mg, Orally, QD	480mg, QD n=8 Participants BBT-176: 480mg, Orally, QD	600mg, QD n=3 Participants BBT-176: 600mg, Orally, QD	160mg, BID n=5 Participants BBT-176: 160mg, Orally, BID	200mg, BID n=9 Participants BBT-176: 200mg, Orally, BID	240mg, BID n=6 Participants BBT-176: 240mg, Orally, BID	480mg QD C2D1 BBT-176: 480mg QD C2D1	600mg QD C1D1 BBT-176: 600mg QD C1D1 \- PK samples were collected at 600 mg QD, but drug exposure was low due to vomiting, making it impossible to determine PK parameters.	600mg QD C2D1 BBT-176: 600mg QD C2D1 \- PK samples were collected at 600 mg QD, but drug exposure was low due to vomiting, making it impossible to determine PK parameters.	160mg BID C1D1 BBT-176: 160mg BID C1D1	160mg BID C2D1 BBT-176: 160mg BID C2D1	200mg BID C1D1 BBT-176: 200mg BID C1D1	200mg BID C2D1 BBT-176: 200mg BID C2D1	240mg BID C1D1 BBT-176: 240mg BID C1D1	240mg BID C2D1 BBT-176: 240mg BID C2D1
(Part 1) Objective Response Rate (ORR)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0, 1, 2, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 1 (C1D1) and Cycle 2 Day 1 (C2D1) (each cycle is 21 days)

Population: The presentation of PK data on C1D1 and C2D1 was due to that the PK samples were collected on those dates. PK samples were collected at 600 mg QD, but drug exposure was low due to vomiting, making it impossible to determine PK parameters.

Peak plasma concentration (Cmax) of BBT-176 from Part 1.

Outcome measures

Outcome measures
Measure	20mg QD n=4 Participants BBT-176: 20mg, Orally, QD	80mg QD n=3 Participants BBT-176: 80mg, Orally, QD	160mg, QD n=3 Participants BBT-176: 160mg, Orally, QD	320mg, QD n=2 Participants BBT-176: 320mg, Orally, QD	480mg, QD n=4 Participants BBT-176: 480mg, Orally, QD	600mg, QD n=3 Participants BBT-176: 600mg, Orally, QD	160mg, BID n=3 Participants BBT-176: 160mg, Orally, BID	200mg, BID n=3 Participants BBT-176: 200mg, Orally, BID	240mg, BID n=8 Participants BBT-176: 240mg, Orally, BID	480mg QD C2D1 n=3 Participants BBT-176: 480mg QD C2D1	600mg QD C1D1 n=3 Participants BBT-176: 600mg QD C1D1 \- PK samples were collected at 600 mg QD, but drug exposure was low due to vomiting, making it impossible to determine PK parameters.	600mg QD C2D1 n=2 Participants BBT-176: 600mg QD C2D1 \- PK samples were collected at 600 mg QD, but drug exposure was low due to vomiting, making it impossible to determine PK parameters.	160mg BID C1D1 n=5 Participants BBT-176: 160mg BID C1D1	160mg BID C2D1 n=3 Participants BBT-176: 160mg BID C2D1	200mg BID C1D1 n=8 Participants BBT-176: 200mg BID C1D1	200mg BID C2D1 n=4 Participants BBT-176: 200mg BID C2D1	240mg BID C1D1 n=6 Participants BBT-176: 240mg BID C1D1	240mg BID C2D1 n=3 Participants BBT-176: 240mg BID C2D1
(Part 1) Pharmacokinetics (PK) Parameters - Peak Concentration (Cmax)	7 ng/mL Standard Deviation 4	10 ng/mL Standard Deviation 5	159 ng/mL Standard Deviation 67	260 ng/mL Standard Deviation 37	240 ng/mL Standard Deviation 75	638 ng/mL Standard Deviation 231	594 ng/mL Standard Deviation 94	1416 ng/mL Standard Deviation 370	1087 ng/mL Standard Deviation 470	2145 ng/mL Standard Deviation 1438	NA ng/mL Standard Deviation NA c. PK samples were collected at 600 mg QD, but values were low or below the level of detection due to vomiting. The sample numbers with measured concentrations were insufficient to determine the PK parameters.	NA ng/mL Standard Deviation NA c. PK samples were collected at 600 mg QD, but values were low or below the level of detection due to vomiting. The sample numbers with measured concentrations were insufficient to determine the PK parameters.	255 ng/mL Standard Deviation 80	1186 ng/mL Standard Deviation 695	354 ng/mL Standard Deviation 88	1784 ng/mL Standard Deviation 358	399 ng/mL Standard Deviation 154	1622 ng/mL Standard Deviation 472

SECONDARY outcome

Timeframe: 0, 1, 2, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 1 (C1D1) and Cycle 2 Day 1 (C2D1) (each cycle is 21 days)

Population: PK data were presented on C1D1 and C2D1 as samples were collected on those days. In the BID regimen, AUC 0-12 was calculated on both days. AUC 0-24 was estimated on C2D1 using AUC 0-12, assuming steady state, but not on C1D1 since steady state was not reached. In Cohort 6 (600mg QD), PK parameters were not determined as BBT-176 was not tolerable, and drug exposure was low due to vomiting.

Area under the plasma concentration-time curve (AUC) of BBT-176 from Part 1.

Outcome measures

Outcome measures
Measure	20mg QD n=4 Participants BBT-176: 20mg, Orally, QD	80mg QD n=3 Participants BBT-176: 80mg, Orally, QD	160mg, QD n=3 Participants BBT-176: 160mg, Orally, QD	320mg, QD n=2 Participants BBT-176: 320mg, Orally, QD	480mg, QD n=4 Participants BBT-176: 480mg, Orally, QD	600mg, QD n=3 Participants BBT-176: 600mg, Orally, QD	160mg, BID n=3 Participants BBT-176: 160mg, Orally, BID	200mg, BID n=3 Participants BBT-176: 200mg, Orally, BID	240mg, BID n=8 Participants BBT-176: 240mg, Orally, BID	480mg QD C2D1 n=3 Participants BBT-176: 480mg QD C2D1	600mg QD C1D1 n=3 Participants BBT-176: 600mg QD C1D1 \- PK samples were collected at 600 mg QD, but drug exposure was low due to vomiting, making it impossible to determine PK parameters.	600mg QD C2D1 n=2 Participants BBT-176: 600mg QD C2D1 \- PK samples were collected at 600 mg QD, but drug exposure was low due to vomiting, making it impossible to determine PK parameters.	160mg BID C1D1 n=3 Participants BBT-176: 160mg BID C1D1	160mg BID C2D1 n=4 Participants BBT-176: 160mg BID C2D1	200mg BID C1D1 n=3 Participants BBT-176: 200mg BID C1D1	200mg BID C2D1 BBT-176: 200mg BID C2D1	240mg BID C1D1 BBT-176: 240mg BID C1D1	240mg BID C2D1 BBT-176: 240mg BID C2D1
(Part 1) PK Parameters - Area Under the Concentration-time Curve (AUC)	91 ng*hr/mL Standard Deviation 42	192 ng*hr/mL Standard Deviation 89	1314 ng*hr/mL Standard Deviation 263	3584 ng*hr/mL Standard Deviation 158	2799 ng*hr/mL Standard Deviation 1030	9652 ng*hr/mL Standard Deviation 5978	8065 ng*hr/mL Standard Deviation 2703	21992 ng*hr/mL Standard Deviation 5494	13938 ng*hr/mL Standard Deviation 6315	38365 ng*hr/mL Standard Deviation 21815	NA ng*hr/mL Standard Deviation NA c. PK samples were collected at 600 mg QD, but values were low or below the level of detection due to vomiting. The sample numbers with measured concentrations were insufficient to determine the PK parameters.	NA ng*hr/mL Standard Deviation NA c. PK samples were collected at 600 mg QD, but values were low or below the level of detection due to vomiting. The sample numbers with measured concentrations were insufficient to determine the PK parameters.	20842 ng*hr/mL Standard Deviation 11511	37564 ng*hr/mL Standard Deviation 8612	33521 ng*hr/mL Standard Deviation 9070	—	—	—

SECONDARY outcome

Timeframe: throughout study completion, approximately 1 year

Population: Due to early termination of the study, Part 2 and analysis was not conducted.

DoR is calculated for every patient with a response to therapy (PR and CR) and is defined as the number of days from the date of initial response to the date of the first documented disease progression/relapse (including clinical progression) or death, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: throughout study completion, approximately 1 year

Population: Due to early termination of the study, Part 2 and analysis was not conducted.

Number of patients experiencing adverse event (AE)s

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Cycle 2 Day 1 (each cycle is 21 days)

Population: Due to early termination of the study, Part 2 and analysis was not conducted.

Plasma BBT-176 concentrations at steady state

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: throughout study completion, approximately 1 year

Population: Due to early termination of the study, Part 2 and analysis was not conducted.

PFS will be calculated for each patient as the number of days from the first day of treatment to the date of the first documented disease progression or date of death, whichever occurs first.

Outcome measures

Outcome data not reported

Adverse Events

20mg QD

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

80mg QD

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

160mg QD

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

320mg QD

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

480mg QD

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

600mg QD

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

160mg BID

Serious events: 3 serious events

Other events: 4 other events

Deaths: 1 deaths

200mg BID

Serious events: 6 serious events

Other events: 9 other events

Deaths: 0 deaths

240mg BID

Serious events: 6 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	20mg QD n=4 participants at risk BBT-176: 20mg, QD, Orally	80mg QD n=3 participants at risk BBT-176: 80mg, QD, Orally	160mg QD n=4 participants at risk BBT-176: 160mg, QD, Orally	320mg QD n=3 participants at risk BBT-176: 320mg, QD, Orally	480mg QD n=8 participants at risk BBT-176: 480mg, QD, Orally	600mg QD n=3 participants at risk BBT-176: 600mg, QD, Orally	160mg BID n=5 participants at risk BBT-176: 160mg, BID, Orally	200mg BID n=9 participants at risk BBT-176: 200mg, BID, Orally	240mg BID n=6 participants at risk BBT-176: 240mg, BID, Orally
Gastrointestinal disorders Gastritis	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 1/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Nausea	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 1/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Infections and infestations Pneumonia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 2/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	22.2% 2/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Cardiac disorders Pericardial effusion	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Infections and infestations COVID-19 related Pneumonia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Infections and infestations Sepsis	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Infections and infestations Urinary tract infection	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
General disorders Pyrexia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
General disorders Sudden death	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Vascular disorders Hypotension	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Investigations Neutrophil count decreased	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Nervous system disorders Skin abrasion	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Skin and subcutaneous tissue disorders Hand dermatitis	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Blood and lymphatic system disorders Anemia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Nervous system disorders Seizure	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.

Other adverse events

Other adverse events
Measure	20mg QD n=4 participants at risk BBT-176: 20mg, QD, Orally	80mg QD n=3 participants at risk BBT-176: 80mg, QD, Orally	160mg QD n=4 participants at risk BBT-176: 160mg, QD, Orally	320mg QD n=3 participants at risk BBT-176: 320mg, QD, Orally	480mg QD n=8 participants at risk BBT-176: 480mg, QD, Orally	600mg QD n=3 participants at risk BBT-176: 600mg, QD, Orally	160mg BID n=5 participants at risk BBT-176: 160mg, BID, Orally	200mg BID n=9 participants at risk BBT-176: 200mg, BID, Orally	240mg BID n=6 participants at risk BBT-176: 240mg, BID, Orally
Investigations Blood pressure increased	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Investigations Lipase increased	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 1/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Investigations Neutrophil count decreased	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Investigations Platelet count decreased	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 2/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Investigations Weight decreased	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Investigations Blood creatinine increased	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Investigations Hepatic enzyme increased	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	66.7% 2/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	50.0% 4/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	100.0% 3/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	44.4% 4/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	83.3% 5/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Nausea	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 1/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	75.0% 6/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	100.0% 3/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	22.2% 2/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	66.7% 4/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Vomiting	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 1/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	50.0% 4/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	100.0% 3/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	50.0% 3/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Stomatitis	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	37.5% 3/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	22.2% 2/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	37.5% 3/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	40.0% 2/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 2/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Blood and lymphatic system disorders Anemia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 2/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 3/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Investigations Amylase Increased	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 1/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 2/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 2/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Gastritis	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 1/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Constipation	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 1/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Cheilitis	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Gastric ulcer	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Gastrointestinal disorders Dysphagia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Skin and subcutaneous tissue disorders Pruritus	25.0% 1/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 1/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Skin and subcutaneous tissue disorders Hand dermatitis	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Investigations Alanine aminotransferase increased	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 1/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Infections and infestations Urinary tract infection	25.0% 1/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	22.2% 2/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Infections and infestations COVID-19 infection	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Infections and infestations Pneumonia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Infections and infestations Influenza	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Cardiac disorders Atrial tachycardia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Eye disorders Vision blurred	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Eye disorders Eczema eyelids	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
General disorders Fatigue	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
General disorders Face oedema	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
General disorders Pyrexia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 2/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
General disorders Swelling face	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
General disorders Asthenia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 2/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	44.4% 4/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 2/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Renal and urinary disorders Haematuria	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	22.2% 2/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 2/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Renal and urinary disorders Proteinuria	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 2/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Respiratory, thoracic and mediastinal disorders Dyspnea exertional	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Psychiatric disorders Delirium	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	12.5% 1/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Vascular disorders Hypertension	25.0% 1/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	20.0% 1/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	11.1% 1/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Nervous system disorders Dizziness	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	25.0% 2/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	16.7% 1/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.
Nervous system disorders Paraesthesia	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	33.3% 1/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/4 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/8 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/3 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/5 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/9 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.	0.00% 0/6 • Safety monitoring was performed up to 30 days (± 3 days) after the last administration of study drug or immediately before initiation of any other cancer therapies, an average of 6 months. Due to early termination of the study, analysis was not conducted.

Additional Information

Clinical Trial Lead

Bridge Biotherapeutics, Inc.

Phone: +82-31-8092-3280

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place