Trial Outcomes & Findings for A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers (NCT NCT04879849)

Last Updated: 2025-09-04

Results Overview

AE: any untoward medical occurrence in participants administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. Severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1: Mild (asymptomatic/mild symptoms; clinical/diagnostic observations only; intervention not indicated); Grade 2: Moderate (minimal, local/noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living \[ADL\]); Grade 3: Severe (severe/medically significant but not immediately life-threatening hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death related to AE.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

34 participants

Primary outcome timeframe

From first dose of study drug administration up to 32 months

Results posted on

2025-09-04

Participant Flow

Participants took part in the study at 5 investigative sites in the United States from 09 September 2021 to 30 April 2024.

Participants with a diagnosis of non-small-cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) or squamous-cell carcinoma of the head and neck (SCCHN) were enrolled to receive radiotherapy, pembrolizumab 200 milligram (mg), intravenous (IV) infusion and TAK-676 IV infusion.

Participant milestones

Participant milestones
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 Milligrams (mg) Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only Participants received radiation therapy with daily image guidance using a fractionated dose of 8 gray (Gy) × 3.
Overall Study STARTED	4	2	4	3	7	6	6	2
Overall Study COMPLETED	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	4	2	4	3	7	6	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 Milligrams (mg) Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only Participants received radiation therapy with daily image guidance using a fractionated dose of 8 gray (Gy) × 3.
Overall Study Lost to Follow-up	0	0	0	1	0	0	0	0
Overall Study Initiation of Another Systemic Anticancer Treatment	3	1	2	0	1	2	3	0
Overall Study Withdrawal by Subject	0	0	0	0	2	0	1	0
Overall Study Progressive Disease	0	0	1	0	0	0	0	0
Overall Study Death	0	0	1	1	1	2	1	2
Overall Study Completion of Follow-up Period and Assessments	0	1	0	1	3	2	0	0
Overall Study Transfer to long term safety study, single-patient Investigational New Drug application, or similar	0	0	0	0	0	0	1	0
Overall Study Reason Not Specified	1	0	0	0	0	0	0	0

Baseline Characteristics

A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg n=3 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=7 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only n=2 Participants Participants received radiation therapy with daily image guidance using a fractionated dose of 8 gray (Gy) × 3.	Total n=34 Participants Total of all reporting groups
Age, Continuous	50.3 years STANDARD_DEVIATION 12.50 • n=5 Participants	65.5 years STANDARD_DEVIATION 6.36 • n=7 Participants	55.0 years STANDARD_DEVIATION 9.20 • n=5 Participants	59.7 years STANDARD_DEVIATION 11.06 • n=4 Participants	66.3 years STANDARD_DEVIATION 16.18 • n=21 Participants	62.0 years STANDARD_DEVIATION 12.38 • n=8 Participants	56.8 years STANDARD_DEVIATION 10.70 • n=8 Participants	73.0 years STANDARD_DEVIATION 7.07 • n=24 Participants	60.4 years STANDARD_DEVIATION 12.56 • n=42 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	0 Participants n=24 Participants	15 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	19 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 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	0 Participants n=24 Participants	1 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants	5 Participants n=8 Participants	5 Participants n=8 Participants	2 Participants n=24 Participants	31 Participants n=42 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	1 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 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	0 Participants n=24 Participants	0 Participants n=42 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	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 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	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	5 Participants n=42 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	24 Participants n=42 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	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	4 Participants n=42 Participants

PRIMARY outcome

Timeframe: From first dose of study drug administration up to 32 months

Population: Safety Analysis Set included participants who received at least 1 dose of radiation.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg n=3 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=7 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only n=2 Participants Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity Number of Participants Reporting Any Grade 3 or Higher TEAEs	0 Participants	1 Participants	4 Participants	1 Participants	3 Participants	2 Participants	4 Participants	1 Participants
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity Number of Participants Reporting one or More TEAEs	4 Participants	2 Participants	4 Participants	3 Participants	7 Participants	5 Participants	6 Participants	2 Participants

PRIMARY outcome

Timeframe: During Cycle 1 (cycle length= 21 days)

Population: The DLT-evaluable Analysis Set included participants who received all Cycle 1 doses of dazostinag, pembrolizumab and 3 doses of radiation without experiencing a DLT by the end of Cycle 1 follow-up and participants who received 3 doses of radiation, pembrolizumab, and the required dazostinag doses up until a DLT during Cycle 1.

A DLT was defined as any TEAE that occurred during Cycle 1 and was considered by investigator to be at least possibly related to TAK-676 in combination with pembrolizumab. TEAEs meeting DLT definitions occurring in later cycles were considered in the determination of recommended phase 2 dose (RP2D) of TAK-676. DLTs were assessed based on NCI CTCAE version 5.0.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg n=3 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=7 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=3 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Number of Participants With Dose-limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: From first dose of study drug administration up to 32 months

Population: Safety Analysis Set included participants who received at least 1 dose of radiation.

TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. An SAE is defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is a medically important event that satisfies any of the following: a) may require intervention to prevent items 1 through 5 above. b) may expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg n=3 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=7 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only n=2 Participants Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Number of Participants Reporting One or More Treatment Emergent Serious Adverse Events (TESAEs)	0 Participants	1 Participants	3 Participants	1 Participants	3 Participants	0 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: From first dose of study drug administration up to 32 months

Population: Safety Analysis Set included participants who received at least 1 dose of radiation.

TEAE: Any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg n=3 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=7 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only n=2 Participants Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Number of Participants With One or More TEAEs Leading to Dose Modifications	2 Participants	1 Participants	3 Participants	0 Participants	4 Participants	3 Participants	4 Participants	1 Participants

PRIMARY outcome

Timeframe: From first dose of study drug administration up to 32 months

Population: Safety Analysis Set included participants who received at least 1 dose of radiation.

TEAE: Any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg n=3 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=7 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only n=2 Participants Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Number of Participants With One or More TEAEs Leading to Treatment Discontinuation	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 32 months

ORR was defined as the percentage of participants who achieved confirmed complete response (cCR) or confirmed partial response (cPR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version1.1 (RECIST, V1.1). Complete Response (CR) for Target Lesions was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 millimeter (mm) and for Nontarget Lesions was defined as disappearance of all nontarget lesions and normalization of tumor marker level and all lymph nodes must be non-pathological in size (\<10 mm short axis). Partial Response (PR) was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. Percentages were rounded off to nearest single decimal place.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg n=3 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=7 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Overall Response Rate (ORR) Assessed by Investigator as Per RECIST v1.1	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	14.3 percentage of participants Interval 0.4 to 57.9	0 percentage of participants Interval 0.0 to 0.0	25.0 percentage of participants Interval 0.6 to 80.6	—

SECONDARY outcome

Timeframe: Up to 32 months

Population: The response-evaluable analysis subset, a subset of the comprehensive response-evaluable analysis set, included participants with measurable disease at baseline and at least 1 post-treatment evaluation. Overall number of participants analyzed signifies participants who had cCR or cPR. Responders without documentation of PD were censored at the date of the last response assessment that was SD or better.

DOR:time from 1st documentation of cPR/better to 1st documentation of progressive disease(PD) for responders(cPR or better).PR:at least 30% decrease in sum of LD of target lesions,with reference of baseline sum LD.2nd assessment confirming PR must have taken place at least 4 weeks after response of interest.PD of Target Lesions:at least 20% increase in sum of LD of target lesions,with reference of smallest sum LD recorded since treatment started/appearance of 1/more new lesions.PD of Nontarget Lesions:unequivocal progression of existing non-target lesions.Responders without documentation of PD were censored at last response assessment that was stable disease(SD) or better.SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,with reference of smallest sum LD since treatment started.Evaluation was determined by investigator according to RECIST, V1.1.2nd assessment confirming CR/PR must have taken place at least 4 weeks after response of interest.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Duration of Response (DOR) For All Tumor Lesions Assessed by Investigator as Per RECIST v1.1	—	—	—	—	9.26 months 95% confidence interval (CI) was not estimable for a single participant.	—	NA months All participants with a cCR or cPR within this arm group were right-censored for duration of response, thus estimates for median duration of response could not be calculated. Also, 95% CI was not estimable for a single participant.	—

SECONDARY outcome

Timeframe: Up to 32 months

TTR was defined as the time from the date of first dose administration to the date of first documented cPR or better as determined by the investigator according to RECIST, V1.1. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Time to Response (TTR) For All Tumor Lesions Assessed by Investigator as Per RECIST v1.1	—	—	—	—	1.38 months 95% CI was not estimable for a single participant.	—	5.39 months 95% CI was not estimable for a single participant.	—

SECONDARY outcome

Timeframe: Up to 32 months

ORR was defined as the percentage of participants who achieve cCR or cPR as determined by the investigator according to Modified itRECIST. CR for Target Lesions was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm and for Nontarget Lesions was defined as disappearance of all nontarget lesions and normalization of tumor marker level and all lymph nodes must be non-pathological in size (\<10 mm short axis). PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg n=3 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=7 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Overall Response Rate Assessed by Investigator as Per Modified Intratumoral Immunotherapy RECIST (Modified itRECIST)	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	14.3 percentage of participants Interval 0.4 to 57.9	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: Up to 32 months

ORRirradiated was defined as the percentage of participants who achieve cCRirradiated or cPRirradiated in the tumor lesions lying within the radiation field as determined by the investigator according to modified itRECIST. CR for Target Lesions was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm and for Nontarget Lesions was defined as disappearance of all nontarget lesions and normalization of tumor marker level and all lymph nodes must be non-pathological in size (\<10 mm short axis). PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg n=3 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=7 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Overall Response Rate For Tumors Within the Radiation Field (ORRirradiated)	50.0 percentage of participants Interval 1.3 to 98.7	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	14.3 percentage of participants Interval 0.4 to 57.9	16.7 percentage of participants Interval 0.4 to 64.1	0 percentage of participants Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: Up to 32 months

ORRnonirradiated was defined as the percentage of participants who achieve cCRnonirradiated or cPRnonirradiated in the tumor lesions lying outside of the radiation field as determined by the investigator according to modified itRECIST. CR for Target Lesions was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm and for Nontarget Lesions was defined as disappearance of all nontarget lesions and normalization of tumor marker level and all lymph nodes must be non-pathological in size (\<10 mm short axis). PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. Percentages were rounded off to the nearest single decimal place.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg n=2 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg n=3 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=7 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg n=6 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=4 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Overall Response Rate For Tumors Outside the Radiation Field (ORRnonirradiated)	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	14.3 percentage of participants Interval 0.4 to 57.9	0 percentage of participants Interval 0.0 to 0.0	25.0 percentage of participants Interval 0.6 to 80.6	—

SECONDARY outcome

Timeframe: Up to 32 months

Population: The Response-evaluable Analysis Subset, a subset of the comprehensive response-evaluable analysis set, included participants with measurable disease at baseline and at least 1 post-treatment evaluation. Overall number of participants analyzed signifies participants who had cCRirradiated or cPRirradiated. Responders without documentation of PD were censored at the date of the last response assessment that was SD or better.

DORirradiated for tumor lesions lying within radiation field: as time from the date of first documentation of a cPRirradiated or better to the date of first documentation of irradiated PD in those lesions for irradiated responders (cPRirradiated or better). PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Irradiated responders without documentation of irradiated PD were censored at the date of last response assessment that is irradiated SD or better. PD of Target Lesions: at least a 20% increase in sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or appearance of 1 or more new lesions. PD of Nontarget Lesions: unequivocal progression of existing non-target lesions. Evaluation was determined by the investigator according to modified itRECIST. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Duration of Response (DOR) For Tumors Within the Radiation Field (DORirradiated)	NA months All participants with a cCR or cPR within this arm group were right-censored for duration of response, thus estimates for median duration of response could not be calculated. Also, 95% CI was not estimable for a single participant.	—	—	—	NA months All participants with a cCR or cPR within this arm group were right-censored for duration of response, thus estimates for median duration of response could not be calculated. Also, 95% CI was not estimable for a single participant.	NA months All participants with a cCR or cPR within this arm group were right-censored for duration of response, thus estimates for median duration of response could not be calculated. Also, 95% CI was not estimable for a single participant.	—	—

SECONDARY outcome

Timeframe: Up to 32 months

Population: The Response-evaluable Analysis Subset, a subset of the comprehensive response-evaluable analysis set, included participants with measurable disease at baseline and at least 1 post-treatment evaluation. Overall number of participants analyzed signifies participants who had cCRnonirradiated or cPRnonirradiated. Responders without documentation of PD were censored at the date of the last response assessment that was SD or better.

DORnonirradiated for tumor lesions lying outside of the radiation field was defined as time from the date of first documentation of a cPRnonirradiated or better to the date of first documentation of nonirradiated PD in those lesions for nonirradiated responders (cPRnonirradiated or better). PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Nonirradiated responders without documentation of nonirradiated PD were censored at the date of last response assessment that is nonirradiated SD or better. Evaluation was determined by the investigator according to modified itRECIST. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Duration of Response (DOR) For Tumors Outside the Radiation Field (DORnonirradiated)	—	—	—	—	NA months All participants with a cCR or cPR within this arm group were right-censored for duration of response, thus estimates for median duration of response could not be calculated. Also, 95% CI was not estimable for a single participant.	—	NA months All participants with a cCR or cPR within this arm group were right-censored for duration of response, thus estimates for median duration of response could not be calculated. Also, 95% CI was not estimable for a single participant.	—

SECONDARY outcome

Timeframe: Up to 32 months

TTRirradiated in the tumor lesions lying within the radiation field was defined as the time from the date of first dose administration to the date of first documented cPRirradiated or better as determined by the investigator according to modified itRECIST. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Time to Response (TTR) For Tumors Within the Radiation Field (TTRirradiated)	1.41 months 95% CI was not estimable for a single participant.	—	—	—	3.45 months 95% CI was not estimable for a single participant.	1.15 months 95% CI was not estimable for a single participant.	—	—

SECONDARY outcome

Timeframe: Up to 32 months

TTR nonirradiated in the tumor lesions lying outside of the radiation field was defined as the time from the date of first dose administration to the date of first documented cPRnonirradiated or better during the study in response-evaluable population as determined by the investigator according to modified itRECIST. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Time to Response (TTR) For Tumors Outside the Radiation Field (TTR Nonirradiated)	—	—	—	—	1.38 months 95% CI was not estimable for a single participant.	—	5.39 months 95% CI was not estimable for a single participant.	—

SECONDARY outcome

Timeframe: Up to approximately 32 months

Population: Overall number of participants analyzed are the participants who had paired samples (both pre-treatment and post-treatment biopsy sample) available for analysis, participants who did not have paired samples were not evaluable for this outcome measure.

The T-cell infiltration levels were calculated as a change from pre-treatment to post-treatment levels. Number of participants who expressed increase in T-cell infiltration levels between the pre-treatment and post-treatment tumor biopsies are reported.

Outcome measures

Outcome measures
Measure	Radiation + Pembrolizumab +Dazostinag 0.2 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.4 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 0.8 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 1.6 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 2.5 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 3.5 mg Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab +Dazostinag 5.0 mg n=1 Participants Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.	Radiation Only Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Number of Participants With Increase in T-Cell Infiltration in Tumor Evaluated by Immunohistochemistry	—	—	—	1 participants	—	—	1 participants	—

Adverse Events

Radiation + Pembrolizumab + Dazostinag 0.2 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Radiation + Pembrolizumab + Dazostinag 0.4 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Radiation + Pembrolizumab + Dazostinag 0.8 mg

Serious events: 3 serious events

Other events: 4 other events

Deaths: 1 deaths

Radiation + Pembrolizumab + Dazostinag 1.6 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Radiation + Pembrolizumab + Dazostinag 2.5 mg

Serious events: 3 serious events

Other events: 7 other events

Deaths: 1 deaths

Radiation + Pembrolizumab + Dazostinag 3.5 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 2 deaths

Radiation + Pembrolizumab + Dazostinag 5.0 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Radiation Only

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Radiation + Pembrolizumab + Dazostinag 0.2 mg n=4 participants at risk Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab + Dazostinag 0.4 mg n=2 participants at risk Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab + Dazostinag 0.8 mg n=4 participants at risk Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab + Dazostinag 1.6 mg n=3 participants at risk Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab + Dazostinag 2.5 mg n=7 participants at risk Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab + Dazostinag 3.5 mg n=6 participants at risk Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab + Dazostinag 5.0 mg n=6 participants at risk Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first.	Radiation Only n=2 participants at risk Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
General disorders Asthenia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Investigations Blood bilirubin increased	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Vascular disorders Deep vein thrombosis	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
General disorders Disease progression	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Dysphagia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Vascular disorders Hypotension	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Nervous system disorders Ischaemic stroke	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Infections and infestations Pneumonia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Cardiac disorders Sinus tachycardia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Nervous system disorders Transient ischaemic attack	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.

Other adverse events

Other adverse events
Measure	Radiation + Pembrolizumab + Dazostinag 0.2 mg n=4 participants at risk Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab + Dazostinag 0.4 mg n=2 participants at risk Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab + Dazostinag 0.8 mg n=4 participants at risk Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab + Dazostinag 1.6 mg n=3 participants at risk Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab + Dazostinag 2.5 mg n=7 participants at risk Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab + Dazostinag 3.5 mg n=6 participants at risk Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first.	Radiation + Pembrolizumab + Dazostinag 5.0 mg n=6 participants at risk Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first.	Radiation Only n=2 participants at risk Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3.
Respiratory, thoracic and mediastinal disorders Pneumonitis	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 2/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Skin and subcutaneous tissue disorders Pruritus	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
General disorders Pyrexia	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	28.6% 2/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Injury, poisoning and procedural complications Radiation pneumonitis	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Injury, poisoning and procedural complications Radiation skin injury	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Abdominal distension	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Investigations Alanine aminotransferase increased	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Investigations Amylase increased	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 2/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	28.6% 2/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 2/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Ascites	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
General disorders Asthenia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Nervous system disorders Balance disorder	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Investigations Blood alkaline phosphatase increased	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Investigations Blood bilirubin increased	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Investigations Blood creatinine increased	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Infections and infestations COVID-19	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
General disorders Chills	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	28.6% 2/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 2/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Psychiatric disorders Confusional state	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Infections and infestations Conjunctivitis viral	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Constipation	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	57.1% 4/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Immune system disorders Contrast media reaction	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 2/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	42.9% 3/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Vascular disorders Deep vein thrombosis	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Dental caries	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Psychiatric disorders Depression	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Product Issues Device malfunction	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	28.6% 2/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 3/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Nervous system disorders Dizziness	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Nervous system disorders Dysgeusia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Dyspepsia	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Dysphagia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	28.6% 2/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Epistaxis	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Nervous system disorders Facial paralysis	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Injury, poisoning and procedural complications Fall	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 2/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
General disorders Fatigue	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	75.0% 3/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	71.4% 5/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 3/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 2/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	100.0% 2/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Gastrooesophageal reflux disease	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Haematochezia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Psychiatric disorders Hallucination	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Nervous system disorders Headache	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Vascular disorders Hypertension	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Metabolism and nutrition disorders Hyponatraemia	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Endocrine disorders Hypoparathyroidism	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Vascular disorders Hypotension	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Endocrine disorders Hypothyroidism	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
General disorders Influenza like illness	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Psychiatric disorders Insomnia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Psychiatric disorders Irritability	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Skin and subcutaneous tissue disorders Lichenoid keratosis	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Injury, poisoning and procedural complications Limb injury	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Investigations Lipase increased	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Investigations Liver function test increased	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Infections and infestations Lung abscess	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Vascular disorders Lymphoedema	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
General disorders Malaise	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spinal cord	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Nausea	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	28.6% 2/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Renal and urinary disorders Nephrolithiasis	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
General disorders Non-cardiac chest pain	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
General disorders Oedema peripheral	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Oesophagitis	50.0% 2/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Eye disorders Optic nerve disorder	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Infections and infestations Oral candidiasis	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
General disorders Pain	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 3/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Cardiac disorders Palpitations	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Nervous system disorders Paraesthesia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Nervous system disorders Parkinsonism	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	50.0% 1/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Infections and infestations Pneumonia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Investigations SARS-CoV-2 test positive	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Immune system disorders Seasonal allergy	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Nervous system disorders Seizure	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Cardiac disorders Sinus tachycardia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Psychiatric disorders Sleep disorder	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Nervous system disorders Somnolence	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Stomatitis	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Nervous system disorders Toxic encephalopathy	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Nervous system disorders Tremor	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour ulceration	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Infections and infestations Vaginitis gardnerella	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	— 0/0 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/1 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	— 0/0 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Ear and labyrinth disorders Vertigo positional	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Gastrointestinal disorders Vomiting	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Investigations Weight decreased	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	14.3% 1/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	16.7% 1/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Investigations Weight increased	25.0% 1/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/4 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	33.3% 1/3 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/7 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/6 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.	0.00% 0/2 • From first dose of study drug administration up to 32 months Safety Analysis Set included participants who received at least 1 dose of radiation.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place