Trial Outcomes & Findings for Pembrolizumab With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease (NCT NCT03095352)

Last Updated: 2025-12-22

Results Overview

The percentage of participants with Complete response (CR), Partial Response (PR), and stable disease (SD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at 18 weeks of treatment in breast cancer patients with chest wall disease treated with pembrolizumab and carboplatin (Arm A) or carboplatin alone (Arm B) will be reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

76 participants

Primary outcome timeframe

Up to 18 weeks

Results posted on

2025-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A: Pembrolizumab + Carboplatin Participants receive carboplatin intravenously (IV) and pembrolizumab IV over 30 minutes on day 1. Participants who are human epidermal growth factor receptor 2 positive (HER2+) also receive trastuzumab IV every 3 weeks. Treatment repeats every 3 weeks for a least 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of carboplatin and pembrolizumab, participants with stable or responding disease receive pembrolizumab monotherapy on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.	Arm B: Carboplatin Monotherapy, then Pembrolizumab for participants who progress only Participants receive carboplatin on day 1. Patients who are HER2+ also receive trastuzumab IV every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment assigned at enrollment STARTED	52	24
Treatment assigned at enrollment COMPLETED	51	24
Treatment assigned at enrollment NOT COMPLETED	1	0
Patients who Progressed on Arm B STARTED	0	16
Patients who Progressed on Arm B COMPLETED	0	16
Patients who Progressed on Arm B NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Pembrolizumab + Carboplatin Participants receive carboplatin intravenously (IV) and pembrolizumab IV over 30 minutes on day 1. Participants who are human epidermal growth factor receptor 2 positive (HER2+) also receive trastuzumab IV every 3 weeks. Treatment repeats every 3 weeks for a least 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of carboplatin and pembrolizumab, participants with stable or responding disease receive pembrolizumab monotherapy on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.	Arm B: Carboplatin Monotherapy, then Pembrolizumab for participants who progress only Participants receive carboplatin on day 1. Patients who are HER2+ also receive trastuzumab IV every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment assigned at enrollment Withdrawal by Subject	1	0

Baseline Characteristics

Pembrolizumab With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Pembrolizumab + Carboplatin n=52 Participants Participants receive carboplatin intravenously (IV) and pembrolizumab IV over 30 minutes on day 1. Participants who are HER2+ also receive trastuzumab IV every 3 weeks. Treatment repeats every 3 weeks for a least 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of carboplatin and pembrolizumab, participants with stable or responding disease receive pembrolizumab monotherapy on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.	Arm B: Carboplatin Monotherapy n=24 Participants Participants receive carboplatin on day 1. Patients who are HER2+ also receive trastuzumab IV every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.	Total n=76 Participants Total of all reporting groups
Age, Continuous	55.19 years STANDARD_DEVIATION 12.11 • n=18 Participants	59.62 years STANDARD_DEVIATION 11.22 • n=102 Participants	56.59 years STANDARD_DEVIATION 11.94 • n=30 Participants
Sex: Female, Male Female	52 Participants n=18 Participants	24 Participants n=102 Participants	76 Participants n=30 Participants
Sex: Female, Male Male	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=18 Participants	3 Participants n=102 Participants	5 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=18 Participants	18 Participants n=102 Participants	65 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=18 Participants	3 Participants n=102 Participants	6 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Asian	6 Participants n=18 Participants	0 Participants n=102 Participants	6 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants	1 Participants n=102 Participants	1 Participants n=30 Participants
Race (NIH/OMB) Black or African American	3 Participants n=18 Participants	4 Participants n=102 Participants	7 Participants n=30 Participants
Race (NIH/OMB) White	39 Participants n=18 Participants	13 Participants n=102 Participants	52 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=18 Participants	0 Participants n=102 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=18 Participants	6 Participants n=102 Participants	10 Participants n=30 Participants
Region of Enrollment United States	52 participants n=18 Participants	24 participants n=102 Participants	76 participants n=30 Participants

PRIMARY outcome

Timeframe: Up to 18 weeks

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin Monotherapy n=24 Participants Participants receive carboplatin on day 1. Patients who are HER2+ also receive trastuzumab IV every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.	Arm BX: Arm B Participants Who Progressed Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants who are HER2+ also receive trastuzumab IV every 3 weeks.	Arm A: Pembrolizumab + Carboplatin n=51 Participants Participants receive carboplatin intravenously (IV) and pembrolizumab IV over 30 minutes on day 1. Participants who are HER2+ also receive trastuzumab IV every 3 weeks. Treatment repeats every 3 weeks for a least 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of carboplatin and pembrolizumab, participants with stable or responding disease receive pembrolizumab monotherapy on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Disease Control Rate (DCR) at 18 Weeks	17 percentage of participants	—	20 percentage of participants

PRIMARY outcome

Timeframe: Up to 18 weeks

PFS is defined as the time in months from observed objective response to disease progression at week 18 and will be summarized using estimates by the Kaplan-Meier method in order to account for any censoring participants by enrolling treatment arms (Arm A and Arm B only)

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin Monotherapy n=24 Participants Participants receive carboplatin on day 1. Patients who are HER2+ also receive trastuzumab IV every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.	Arm BX: Arm B Participants Who Progressed Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants who are HER2+ also receive trastuzumab IV every 3 weeks.	Arm A: Pembrolizumab + Carboplatin n=51 Participants Participants receive carboplatin intravenously (IV) and pembrolizumab IV over 30 minutes on day 1. Participants who are HER2+ also receive trastuzumab IV every 3 weeks. Treatment repeats every 3 weeks for a least 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of carboplatin and pembrolizumab, participants with stable or responding disease receive pembrolizumab monotherapy on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Median Progression Free Survival (PFS) at 18 Weeks	2.63 months Interval 1.44 to 4.17	—	2.06 months Interval 1.38 to 3.12

SECONDARY outcome

Timeframe: Up to 18 weeks

The percentage of participants with Complete response (CR), Partial Response (PR), and stable disease (SD) as defined by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) at 18 weeks of treatment in breast cancer patients with chest wall disease treated with pembrolizumab and carboplatin (Arm A) or carboplatin alone (Arm B) and also based on PD-L1 expression

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin Monotherapy n=24 Participants Participants receive carboplatin on day 1. Patients who are HER2+ also receive trastuzumab IV every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.	Arm BX: Arm B Participants Who Progressed Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants who are HER2+ also receive trastuzumab IV every 3 weeks.	Arm A: Pembrolizumab + Carboplatin n=51 Participants Participants receive carboplatin intravenously (IV) and pembrolizumab IV over 30 minutes on day 1. Participants who are HER2+ also receive trastuzumab IV every 3 weeks. Treatment repeats every 3 weeks for a least 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of carboplatin and pembrolizumab, participants with stable or responding disease receive pembrolizumab monotherapy on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
DCR by Immune-related (ir) RECIST at 18 Weeks	17 percentage of participants	—	18 percentage of participants

SECONDARY outcome

Timeframe: Up to 18 weeks

ORR will be presented as the percentage of participants with CR or PR as determined by RECIST criteria.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin Monotherapy n=24 Participants Participants receive carboplatin on day 1. Patients who are HER2+ also receive trastuzumab IV every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.	Arm BX: Arm B Participants Who Progressed Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants who are HER2+ also receive trastuzumab IV every 3 weeks.	Arm A: Pembrolizumab + Carboplatin n=51 Participants Participants receive carboplatin intravenously (IV) and pembrolizumab IV over 30 minutes on day 1. Participants who are HER2+ also receive trastuzumab IV every 3 weeks. Treatment repeats every 3 weeks for a least 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of carboplatin and pembrolizumab, participants with stable or responding disease receive pembrolizumab monotherapy on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Objective Response Rate (ORR)	12.5 percentage of participants	—	8 percentage of participants

SECONDARY outcome

Timeframe: Up to 18 months

Adverse events will be graded and recorded according to NCI CTCAE Version 4.0 up to 30 days after the last treatment. Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) did not need to be recorded as adverse events.

Outcome measures

Outcome measures
Measure	Arm B: Carboplatin Monotherapy n=24 Participants Participants receive carboplatin on day 1. Patients who are HER2+ also receive trastuzumab IV every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.	Arm BX: Arm B Participants Who Progressed n=16 Participants Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants who are HER2+ also receive trastuzumab IV every 3 weeks.	Arm A: Pembrolizumab + Carboplatin n=51 Participants Participants receive carboplatin intravenously (IV) and pembrolizumab IV over 30 minutes on day 1. Participants who are HER2+ also receive trastuzumab IV every 3 weeks. Treatment repeats every 3 weeks for a least 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of carboplatin and pembrolizumab, participants with stable or responding disease receive pembrolizumab monotherapy on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Number of Participants With Treatment-related Adverse Events (AEs)	12 Participants	6 Participants	33 Participants

Adverse Events

Arm A: Pembrolizumab + Carboplatin

Serious events: 15 serious events

Other events: 43 other events

Deaths: 15 deaths

Arm B: Carboplatin Monotherapy

Serious events: 2 serious events

Other events: 19 other events

Deaths: 2 deaths

Arm BX: Participants who progressed on Arm B

Serious events: 4 serious events

Other events: 12 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Laura Huppert, MD

University of California, San Francisco

Phone: (415) 476-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A: Pembrolizumab + Carboplatin n=52 participants at risk Participants receive carboplatin intravenously (IV) and pembrolizumab IV over 30 minutes on day 1. Participants who are HER2+ also receive trastuzumab IV every 3 weeks. Treatment repeats every 3 weeks for a least 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of carboplatin and pembrolizumab, participants with stable or responding disease receive pembrolizumab monotherapy on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.	Arm B: Carboplatin Monotherapy n=24 participants at risk Participants receive carboplatin on day 1. Patients who are HER2+ also receive trastuzumab IV every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.	Arm BX: Participants who progressed on Arm B n=16 participants at risk Participants with disease progression (PD) are eligible to receive pembrolizumab on day 1 of each cycle (crossover). Carboplatin may be continued or added back into the treatment regimen at the investigator's discretion. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Participants who are HER2+ also receive trastuzumab IV every 3 weeks.
Blood and lymphatic system disorders Anemia	3.8% 2/52 • Number of events 3 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Blood and lymphatic system disorders Febrile Neurtopenia	0.00% 0/52 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	6.2% 1/16 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Ear and labyrinth disorders Vertigo	1.9% 1/52 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Endocrine disorders Adrenal Insufficiency	1.9% 1/52 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Gastrointestinal disorders Nausea	1.9% 1/52 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Gastrointestinal disorders Dysphagia	1.9% 1/52 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Gastrointestinal disorders Constipation	0.00% 0/52 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	4.2% 1/24 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Infections and infestations Sepsis	5.8% 3/52 • Number of events 3 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Infections and infestations Urinary Tract Infection	0.00% 0/52 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	4.2% 1/24 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Infections and infestations Wound Infection	1.9% 1/52 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Injury, poisoning and procedural complications Vascular Access Complication	1.9% 1/52 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Investigations Platelet Count Decreased	3.8% 2/52 • Number of events 3 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Metabolism and nutrition disorders Hypercalcemia	1.9% 1/52 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Nervous system disorders Stroke	0.00% 0/52 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	6.2% 1/16 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspenea	1.9% 1/52 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	4.2% 1/24 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	12.5% 2/16 • Number of events 2 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.9% 1/52 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.9% 1/52 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.9% 1/52 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	1.9% 1/52 • Number of events 1 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/24 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.	0.00% 0/16 • Up to 18 months Per protocol, Grade 1 laboratory abnormalities and white blood cell differential abnormalities excluding neutrophils (i.e., lymphocytes, monocytes, basophils, etc.) were not recorded as AEs.