Trial Outcomes & Findings for A Study of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-1088-002) (NCT NCT05394350)

Last Updated: 2024-11-08

Results Overview

A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Per protocol participants who switched over from MK-1088 monotherapy into MK-1088 100 mg + Pembrolizumab combination therapy completed the DLT evaluation period in the monotherapy arm assigned. Percentage of participants who experienced a DLT are presented.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Up to 21 days

Results posted on

2024-11-08

Participant Flow

The study was closed to enrollment on 04-MAY-2023 for all participants, and no participants remain on treatment with MK-1088. Part 2 of the study was not initiated.

Per protocol two participants who progressed by radiographic evaluation on monotherapy with MK-1088 at the investigator's discretion and after consultation with the Sponsor, switched over to combination treatment arm of MK-1088 and pembrolizumab.

Participant milestones

Participant milestones
Measure	MK-1088 100 mg Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 400 mg Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 600 mg Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg + Pembrolizumab Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)
Overall Study STARTED	3	3	11	3	3	4
Overall Study Switch Over to MK-1088 100 mg + Pembrolizumab	0	1	1	0	0	0
Overall Study COMPLETED	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	3	11	3	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-1088 100 mg Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 400 mg Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 600 mg Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg + Pembrolizumab Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)
Overall Study Death	2	2	4	0	1	0
Overall Study Study terminated by sponsor	1	1	7	3	2	4

Baseline Characteristics

A Study of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-1088-002)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-1088 100 mg n=3 Participants Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg n=3 Participants Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 400 mg n=11 Participants Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 600 mg n=3 Participants Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab n=3 Participants Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg + Pembrolizumab n=4 Participants Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	Total n=27 Participants Total of all reporting groups
Age, Continuous	66.7 Years STANDARD_DEVIATION 13.6 • n=5 Participants	58.7 Years STANDARD_DEVIATION 24.8 • n=7 Participants	59.5 Years STANDARD_DEVIATION 13.5 • n=5 Participants	62.7 Years STANDARD_DEVIATION 4.9 • n=4 Participants	61.0 Years STANDARD_DEVIATION 10.1 • n=21 Participants	55.8 Years STANDARD_DEVIATION 11.6 • n=8 Participants	60.1 Years STANDARD_DEVIATION 12.9 • n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	10 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	17 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	24 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	24 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to 21 days

Population: All participants who received at least one dose of study intervention and met the criteria for DLT evaluability

Outcome measures

Outcome measures
Measure	MK-1088 100 mg n=3 Participants Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg n=3 Participants Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 400 mg n=11 Participants Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 600 mg n=3 Participants Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab n=3 Participants Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg + Pembrolizumab n=4 Participants Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab Switchover Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)
Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)	0.0 Percentage of Participants	0.0 Percentage of Participants	9.09 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants	0.0 Percentage of Participants	—

PRIMARY outcome

Timeframe: Up to ~13 months

Population: All participants who received at least one dose of study intervention

An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Safety data from participants who experienced disease progression in the monotherapy arm and crossed over into the combination arm are summarized in their initial monotherapy dose group until the time of cross over and are summarized separately thereafter. The percentage of participants who experienced an AE are presented.

Outcome measures

Outcome measures
Measure	MK-1088 100 mg n=3 Participants Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg n=3 Participants Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 400 mg n=11 Participants Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 600 mg n=3 Participants Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab n=3 Participants Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg + Pembrolizumab n=4 Participants Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab Switchover n=2 Participants Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)
Percentage of Participants Experiencing an Adverse Event (AE)	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants	100.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to ~10 months

Population: All participants who received at least one dose of study intervention

Outcome measures

Outcome measures
Measure	MK-1088 100 mg n=3 Participants Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg n=3 Participants Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 400 mg n=11 Participants Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 600 mg n=3 Participants Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab n=3 Participants Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg + Pembrolizumab n=4 Participants Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab Switchover n=2 Participants Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)
Percentage of Participants Discontinuing Study Treatment Due to an AE	0.0 Percentage of participants	0.0 Percentage of participants	9.1 Percentage of participants	0.0 Percentage of participants	66.7 Percentage of participants	75.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Pre-dose and 1, 2, 4, and 8 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1; Pre-dose on Cycle 1 Day 2 and Cycle 2 Day 2; Pre-dose on Cycle 3, Cycle 4 and every 4 cycles up to ~3.5 months. Each cycle = 21 days

Population: All participants who complied with the protocol sufficiently to ensure that their data will be likely to show the effects of treatment, according to the underlying scientific model. Only the per protocol analysis set (excluding the data from the participants after switching over to MK-1088 100 mg and Pembrolizumab) were analyzed for pharmacokinetic (PK) data.

AUC of MK-1088 determined by blood samples collected pre-dose and at designated timepoints post-dose are presented.

Outcome measures

Outcome measures
Measure	MK-1088 100 mg n=3 Participants Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg n=3 Participants Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 400 mg n=11 Participants Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 600 mg n=3 Participants Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab n=3 Participants Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg + Pembrolizumab n=4 Participants Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab Switchover Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)
Area Under the Plasma Concentration-time Curve (AUC) of MK-1088 Cycle 1	31.9 hr*μmol/L Geometric Coefficient of Variation 105.2	26.1 hr*μmol/L Geometric Coefficient of Variation 95.1	98.4 hr*μmol/L Geometric Coefficient of Variation 38.5	99.4 hr*μmol/L Geometric Coefficient of Variation 43.9	21.8 hr*μmol/L Geometric Coefficient of Variation 51.2	49.3 hr*μmol/L Geometric Coefficient of Variation 50.8	—
Area Under the Plasma Concentration-time Curve (AUC) of MK-1088 Cycle 2	39.0 hr*μmol/L Geometric Coefficient of Variation 46.6	39.5 hr*μmol/L Geometric Coefficient of Variation 145.4	197.0 hr*μmol/L Geometric Coefficient of Variation 46.4	188.0 hr*μmol/L Geometric Coefficient of Variation 90.6	29.7 hr*μmol/L Geometric Coefficient of Variation 97.1	102.0 hr*μmol/L Geometric Coefficient of Variation 17.6	—

SECONDARY outcome

Cmax of MK-1088 determined by blood samples collected pre-dose and at designated timepoints post-dose are presented.

Outcome measures

Outcome measures
Measure	MK-1088 100 mg n=3 Participants Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg n=3 Participants Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 400 mg n=11 Participants Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 600 mg n=3 Participants Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab n=3 Participants Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg + Pembrolizumab n=4 Participants Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab Switchover Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)
Maximum Plasma Concentration (Cmax) of MK-1088 Cycle 1	2.58 μmol/L Geometric Coefficient of Variation 61.8	2.17 μmol/L Geometric Coefficient of Variation 50.8	6.63 μmol/L Geometric Coefficient of Variation 36.7	7.70 μmol/L Geometric Coefficient of Variation 46.4	1.41 μmol/L Geometric Coefficient of Variation 62.4	3.29 μmol/L Geometric Coefficient of Variation 83.1	—
Maximum Plasma Concentration (Cmax) of MK-1088 Cycle 2	2.82 μmol/L Geometric Coefficient of Variation 31.9	3.27 μmol/L Geometric Coefficient of Variation 92.0	11.6 μmol/L Geometric Coefficient of Variation 31.8	11.6 μmol/L Geometric Coefficient of Variation 79.9	1.80 μmol/L Geometric Coefficient of Variation 117.4	6.32 μmol/L Geometric Coefficient of Variation 30.2	—

SECONDARY outcome

Timeframe: Up to ~13 months

Population: All participants with a screening/baseline scan that showed measurable disease by the investigator's assessment, and received at least 1 dose of study intervention

ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by investigator. Efficacy data from participants who experienced disease progression in the monotherapy arm and crossed over into the combination arm will be summarized in their initial monotherapy dose group until the time of cross over and will be summarized separately thereafter. The percentage of participants who experience a CR or PR as assessed by the investigator based on RECIST 1.1 is presented.

Outcome measures

Outcome measures
Measure	MK-1088 100 mg n=2 Participants Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg n=3 Participants Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 400 mg n=11 Participants Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 600 mg n=3 Participants Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab n=3 Participants Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg + Pembrolizumab n=4 Participants Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab Switchover n=2 Participants Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-Modified RECIST 1.1 as Assessed by Investigator	0.0 Percentage of participants Interval 0.0 to 84.2	0.0 Percentage of participants Interval 0.0 to 70.8	0.0 Percentage of participants Interval 0.0 to 28.5	0.0 Percentage of participants Interval 0.0 to 70.8	33.3 Percentage of participants Interval 0.8 to 90.6	0.0 Percentage of participants Interval 0.0 to 60.2	0.0 Percentage of participants Interval 0.0 to 84.2

Adverse Events

MK-1088 100 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

MK-1088 200 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

MK-1088 400 mg

Serious events: 6 serious events

Other events: 11 other events

Deaths: 4 deaths

MK-1088 600 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

MK 1088 100 mg + Pembrolizumab

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

MK-1088 200 mg + Pembrolizumab

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

MK-1088 100 mg + Pembrolizumab Swicthover

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MK-1088 100 mg n=3 participants at risk Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg n=3 participants at risk Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 400 mg n=11 participants at risk Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 600 mg n=3 participants at risk Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK 1088 100 mg + Pembrolizumab n=3 participants at risk Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg + Pembrolizumab n=4 participants at risk Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab Swicthover n=2 participants at risk Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Cardiac failure congestive	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Ileus	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Incarcerated umbilical hernia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Complication associated with device	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Viral labyrinthitis	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	66.7% 2/3 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	27.3% 3/11 • Number of events 3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Dizziness	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Transient ischaemic attack	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Ureteric stenosis	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.

Other adverse events

Other adverse events
Measure	MK-1088 100 mg n=3 participants at risk Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg n=3 participants at risk Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 400 mg n=11 participants at risk Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 600 mg n=3 participants at risk Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK 1088 100 mg + Pembrolizumab n=3 participants at risk Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 200 mg + Pembrolizumab n=4 participants at risk Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)	MK-1088 100 mg + Pembrolizumab Swicthover n=2 participants at risk Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \~24 months)
Nervous system disorders Syncope	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Haematuria	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Urine odour abnormal	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Psychiatric disorders Insomnia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Renal and urinary disorders Chromaturia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Eye disorders Dry eye	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	18.2% 2/11 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	18.2% 2/11 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 2/4 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Ascites	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Constipation	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	27.3% 3/11 • Number of events 3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 2/4 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	100.0% 3/3 • Number of events 3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	18.2% 2/11 • Number of events 3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 2/4 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Gingival bleeding	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Nausea	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	36.4% 4/11 • Number of events 6 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	18.2% 2/11 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	66.7% 2/3 • Number of events 3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Chest pain	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Early satiety	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Fatigue	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	66.7% 2/3 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	36.4% 4/11 • Number of events 4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	66.7% 2/3 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	100.0% 2/2 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Feeling cold	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders General physical health deterioration	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Influenza like illness	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Localised oedema	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Mucosal inflammation	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Oedema	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Oedema peripheral	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Pain	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
General disorders Pyrexia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Immune system disorders Allergy to arthropod bite	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Cystitis	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Nasopharyngitis	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Accidental overdose	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Head injury	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	18.2% 2/11 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 2/4 • Number of events 3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	18.2% 2/11 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 2/4 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood bilirubin increased	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood creatinine increased	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	66.7% 2/3 • Number of events 3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Blood urine present	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations C-reactive protein increased	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	18.2% 2/11 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Weight decreased	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Investigations Weight increased	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	66.7% 2/3 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	18.2% 2/11 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	36.4% 4/11 • Number of events 6 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 2/4 • Number of events 3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Dizziness	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	18.2% 2/11 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Headache	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	100.0% 4/4 • Number of events 4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Paraesthesia	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Nervous system disorders Somnolence	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 2/4 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Haemoptysis	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Painful respiration	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Pulmonary pain	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Acne	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	9.1% 1/11 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	75.0% 3/4 • Number of events 3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Haematoma	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Hot flush	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	50.0% 1/2 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Hypertension	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	33.3% 1/3 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Hypotension	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Intermittent claudication	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	25.0% 1/4 • Number of events 1 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
Vascular disorders Lymphoedema	33.3% 1/3 • Number of events 2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/11 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/3 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/4 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.	0.00% 0/2 • Death and adverse events up to ~13 months Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER