Trial Outcomes & Findings for TVEC and Preop Radiation for Sarcoma (8 ml Dose) (NCT NCT04599062)

Last Updated: 2026-01-29

Results Overview

A DLT is defined as any of the following talimogene laherparepvec-related toxicity or related to the combination of talimogene laherparepvec and radiation therapy during treatment and up to 4 weeks after the last talimogene laherparepvec injection: Grade 3 or greater immune-mediated adverse events, Grade 3 or greater allergic reactions, any grade plasmacytoma, any other unexpected grade 3 or greater hematologic or non-hematologic toxicity, with the exceptions of: any grade of alopecia, expected radiation related skin toxicity of any grade, Grade 3 arthralgia or myalgia, brief (\< 1 week) grade 3 fatigue, Grade 3 fever, Grade 3 diarrhea or vomiting responding to supportive case.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

8 participants

Primary outcome timeframe

14 weeks

Results posted on

2026-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Talimogene Laherparepvec in Combination With Radiotherapy-Phase I Talimogene Laherparepvec Dose Levels: Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.	Talimogene Laherparepvec in Combination With Radiotherapy-Phase II Talimogene Laherparepvec Dose Level: Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
Overall Study STARTED	6	2
Overall Study COMPLETED	5	2
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Talimogene Laherparepvec in Combination With Radiotherapy-Phase I Talimogene Laherparepvec Dose Levels: Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.	Talimogene Laherparepvec in Combination With Radiotherapy-Phase II Talimogene Laherparepvec Dose Level: Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
Overall Study Physician Decision	1	0

Baseline Characteristics

TVEC and Preop Radiation for Sarcoma (8 ml Dose)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Talimogene Laherparepvec in Combination With Radiotherapy-Phase I n=6 Participants Talimogene Laherparepvec in combination with radiotherapy Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly Talimogene Laherparepvec: Talimogene Laherparepvec Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.	Talimogene Laherparepvec in Combination With Radiotherapy-Phase II n=2 Participants Talimogene Laherparepvec Dose Level: Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=35 Participants	2 Participants n=4328 Participants	3 Participants n=8687 Participants
Age, Categorical >=65 years	5 Participants n=35 Participants	0 Participants n=4328 Participants	5 Participants n=8687 Participants
Age, Continuous	72 years n=35 Participants	44 years n=4328 Participants	65 years n=8687 Participants
Sex: Female, Male Female	1 Participants n=35 Participants	1 Participants n=4328 Participants	2 Participants n=8687 Participants
Sex: Female, Male Male	5 Participants n=35 Participants	1 Participants n=4328 Participants	6 Participants n=8687 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=35 Participants	2 Participants n=4328 Participants	7 Participants n=8687 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=35 Participants	0 Participants n=4328 Participants	1 Participants n=8687 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Asian	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Black or African American	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) White	6 Participants n=35 Participants	1 Participants n=4328 Participants	7 Participants n=8687 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	1 Participants n=4328 Participants	1 Participants n=8687 Participants
Region of Enrollment United States	6 participants n=35 Participants	2 participants n=4328 Participants	8 participants n=8687 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: 6 participants enrolled in the Phase 1 portion (Talimogene Laherparepvec Dose 0) and completed treatment, radiation, and surgical resection.

Outcome measures

Outcome measures
Measure	Talimogene Laherparepvec in Combination With Radiotherapy-Phase I Cohort n=6 Participants Talimogene Laherparepvec in combination with radiotherapy Talimogene Laherparepvec Dose Levels: Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: 8 participants received Dose Level 0 and were included in the analysis for pathologic tumor necrosis

Pathologic tumor necrosis rate is defined as the percentage of subjects with pathologic tumor necrosis ≥ 90%.

Outcome measures

Outcome measures
Measure	Talimogene Laherparepvec in Combination With Radiotherapy-Phase I Cohort n=8 Participants Talimogene Laherparepvec in combination with radiotherapy Talimogene Laherparepvec Dose Levels: Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
Pathologic Tumor Necrosis Rate	4 Participants

SECONDARY outcome

Timeframe: 24 months

Overall response rate is defined as the percentage of patients with a confirmed complete or partial response per RECIST v1.1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Progression-free survival is defined as the time from treatment initiation to the date of first documentation of disease progression or death due to any cause. Otherwise, patients are censored at the date of last radiographic assessment for progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Overall survival is defined as the time from treatment initiation to death due to any cause. Patients still alive are censored at last date known to be alive.

Outcome measures

Outcome data not reported

Adverse Events

Talimogene Laherparepvec in Combination With Radiotherapy-Phase I

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Talimogene Laherparepvec in Combination With Radiotherapy-Phase II

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Varun Monga, MD

University of Iowa, Holden Comprehensive Cancer Center

Phone: 319-384-9497

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Talimogene Laherparepvec in Combination With Radiotherapy-Phase I n=6 participants at risk Talimogene Laherparepvec in combination with radiotherapy Talimogene Laherparepvec Dose Levels: Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly Talimogene Laherparepvec: Talimogene Laherparepvec Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.	Talimogene Laherparepvec in Combination With Radiotherapy-Phase II n=2 participants at risk Talimogene Laherparepvec Dose Level: Dose 0 = talimogene laherparepvec up to 8.0 mL of 108 PFU/mL dosed weekly Radiotherapy: Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
Blood and lymphatic system disorders Anemia	16.7% 1/6 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Gastrointestinal disorders Constipation	33.3% 2/6 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Gastrointestinal disorders Diarrhea	33.3% 2/6 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	50.0% 1/2 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Gastrointestinal disorders Nausea	50.0% 3/6 • Number of events 4 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	50.0% 1/2 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Gastrointestinal disorders Vomiting	33.3% 2/6 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
General disorders and administration site conditions Chills	83.3% 5/6 • Number of events 7 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	100.0% 2/2 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
General disorders and administration site conditions Edema limbs	16.7% 1/6 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	50.0% 1/2 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
General disorders and administration site conditions Fatigue	83.3% 5/6 • Number of events 6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
General disorders and administration site conditions Fever	50.0% 3/6 • Number of events 5 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	100.0% 2/2 • Number of events 4 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
General disorders and administration site conditions Flu like symptoms	16.7% 1/6 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
General disorders and administration site conditions General disorders and administration site conditions - Other, specify	0.00% 0/6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	50.0% 1/2 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
General disorders and administration site conditions Pain	0.00% 0/6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	50.0% 1/2 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Infections and infestations Infections and infestations - Other, specify	16.7% 1/6 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Infections and infestations Pelvic infection	0.00% 0/6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	50.0% 1/2 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Infections and infestations Tooth infection	16.7% 1/6 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Injury, poisoning and procedural complications Bruising	33.3% 2/6 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Injury, poisoning and procedural complications Dermatitis radiation	66.7% 4/6 • Number of events 5 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	100.0% 2/2 • Number of events 3 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Injury, poisoning and procedural complications Fall	33.3% 2/6 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Investigations Creatinine increased	0.00% 0/6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	50.0% 1/2 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Investigations Investigations - Other, specify	0.00% 0/6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	50.0% 1/2 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Investigations Weight loss	16.7% 1/6 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Metabolism and nutrition disorders Anorexia	33.3% 2/6 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	50.0% 1/2 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	16.7% 1/6 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	50.0% 1/2 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	33.3% 2/6 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	50.0% 1/2 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Nervous system disorders Dizziness	33.3% 2/6 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	50.0% 1/2 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Reproductive system and breast disorders Pelvic pain	0.00% 0/6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	50.0% 1/2 • Number of events 2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Skin and subcutaneous tissue disorders Pain of skin	16.7% 1/6 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	16.7% 1/6 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Vascular disorders Hypertension	33.3% 2/6 • Number of events 4 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	0.00% 0/2 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.
Vascular disorders Hypotension	0.00% 0/6 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.	50.0% 1/2 • Number of events 1 • Information regarding the occurrence of adverse events was collected from the time the subject signed the informed consent form and throughout their participation in the study, through a period of 30 days after the last dose of study drug, up to 14 weeks.