Trial Outcomes & Findings for Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases (NCT NCT02858869)

Last Updated: 2026-03-09

Results Overview

Number of dose limiting toxicity events defined as Radiation Therapy Oncology Group grade 3 central nervous system toxicities which are irreversible severe neurological symptoms requiring medications. Toxicity events for each arm will be reported, and 95% confidence intervals will be estimated using the Clopper-Pearson method. Number of with DLT (%).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

25 participants

Primary outcome timeframe

3 months after first pembrolizumab dose

Results posted on

2026-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions) Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat Q3W for at least 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo 5 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions) Patients receive pembrolizumab IV as in Arm A. Patients undergo 3 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction) Patients receive pembrolizumab IV as in Arm A. Patients undergo 1 SRS fraction between days 2-3 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS
Overall Study STARTED	6	12	7
Overall Study COMPLETED	6	12	7
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions) n=6 Participants Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat Q3W for at least 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo 5 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions) n=12 Participants Patients receive pembrolizumab IV as in Arm A. Patients undergo 3 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction) n=7 Participants Patients receive pembrolizumab IV as in Arm A. Patients undergo 1 SRS fraction between days 2-3 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Total n=25 Participants Total of all reporting groups
Age, Continuous	63.2 years n=68 Participants	63.3 years n=69 Participants	56.9 years n=137 Participants	63 years n=565 Participants
Sex: Female, Male Female	2 Participants n=68 Participants	5 Participants n=69 Participants	3 Participants n=137 Participants	10 Participants n=565 Participants
Sex: Female, Male Male	4 Participants n=68 Participants	7 Participants n=69 Participants	4 Participants n=137 Participants	15 Participants n=565 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=68 Participants	2 Participants n=69 Participants	0 Participants n=137 Participants	2 Participants n=565 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=68 Participants	10 Participants n=69 Participants	7 Participants n=137 Participants	23 Participants n=565 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=565 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=565 Participants
Race (NIH/OMB) Asian	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=565 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=565 Participants
Race (NIH/OMB) Black or African American	1 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	1 Participants n=565 Participants
Race (NIH/OMB) White	5 Participants n=68 Participants	12 Participants n=69 Participants	7 Participants n=137 Participants	24 Participants n=565 Participants
Race (NIH/OMB) More than one race	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=565 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=565 Participants
Region of Enrollment United States	6 participants n=68 Participants	12 participants n=69 Participants	7 participants n=137 Participants	25 participants n=565 Participants
Previous systemic therapies (medications that travel throughout the body to destroy cancer cells)	1 Participants n=68 Participants	6 Participants n=69 Participants	5 Participants n=137 Participants	12 Participants n=565 Participants

PRIMARY outcome

Timeframe: 3 months after first pembrolizumab dose

Outcome measures

Outcome measures
Measure	Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions) n=6 Participants Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat Q3W for at least 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo 5 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions) n=12 Participants Patients receive pembrolizumab IV as in Arm A. Patients undergo 3 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction) n=7 Participants Patients receive pembrolizumab IV as in Arm A. Patients undergo 1 SRS fraction between days 2-3 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS
Dose Limiting Toxicities	0 Participants Interval 0.0 to 46.0	0 Participants Interval 0.0 to 26.0	0 Participants Interval 0.0 to 41.0

SECONDARY outcome

Timeframe: From first treatment on cycle 1, day 1 to the earlier of date of death and/or last follow up, assessed up to 3 years

Time from treatment initiation to death from any cause. Those who were alive were censored at last follow-up. Estimated using the Kaplan-Meier product-limit method. Median and 95% CI using Brookmeyer-Crowley method reported.

Outcome measures

Outcome measures
Measure	Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions) n=6 Participants Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat Q3W for at least 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo 5 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions) n=12 Participants Patients receive pembrolizumab IV as in Arm A. Patients undergo 3 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction) n=7 Participants Patients receive pembrolizumab IV as in Arm A. Patients undergo 1 SRS fraction between days 2-3 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS
Overall Survival	NA Months Interval 0.99 to SAS leaves the median survival blank in PROC LIFETEST when the Kaplan-Meier survival probability is exactly 0.5 because the median is technically defined as the first time point where the survival function drops below 0.5. If the curve hits 0.5 and stops, or if censored observations prevent the curve from falling strictly below 0.5, the median is not technically reached.	32.8 Months Interval 4.89 to Not reached.	12.2 Months Interval 2.86 to Not reached.

SECONDARY outcome

Timeframe: Up to 12 months after first pembrolizumab dose

Defined as proportion with evidence of necrosis on MRI images (radiographic evidence or radionecrosis) and a patient having neurological symptoms attributed to the location where the radiosurgery was done. The proportion will be reported, and a 95% confidence interval will be estimated using the Clopper-Pearson method. Number with symptomatic radiation necrosis.

Outcome measures

Outcome measures
Measure	Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions) n=6 Participants Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat Q3W for at least 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo 5 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions) n=12 Participants Patients receive pembrolizumab IV as in Arm A. Patients undergo 3 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction) n=7 Participants Patients receive pembrolizumab IV as in Arm A. Patients undergo 1 SRS fraction between days 2-3 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS
Rate of Symptomatic Radiation Necrosis	0 Percentage of participants Interval 0.0 to 46.0	16.7 Percentage of participants Interval 2.1 to 48.0	14.3 Percentage of participants Interval 0.3 to 58.0

SECONDARY outcome

Timeframe: From the first treatment on cycle 1, day 1 to the earlier of the recurrence event and/or last follow up/death, at least 6 months

Defined as proportion with a best overall response of stable disease or better for intracranial lesions present at baseline. Assessed using RECIST and immune RECIST Criteria. The proportion will be reported, and a 95% confidence interval will be estimated using the Clopper-Pearson method. Number with clinical benefit (%).

Outcome measures

Outcome measures
Measure	Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions) n=5 Participants Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat Q3W for at least 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo 5 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions) n=10 Participants Patients receive pembrolizumab IV as in Arm A. Patients undergo 3 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction) n=5 Participants Patients receive pembrolizumab IV as in Arm A. Patients undergo 1 SRS fraction between days 2-3 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS
Clinical Benefit (Intra-cranial)	100 Percentage of participants Interval 48.0 to 100.0	60 Percentage of participants Interval 26.0 to 88.0	20 Percentage of participants Interval 0.5 to 72.0

SECONDARY outcome

Timeframe: From the first treatment on cycle 1, day 1 to the earlier of the recurrence event and/or last follow up/death, at least 6 months

Defined as proportion with a best overall response of stable disease or better for extra-cranial lesions present at baseline. Assessed using RECIST and immune RECIST Criteria. Assessed using RECIST and immune RECIST Criteria. The proportion will be reported, and a 95% confidence interval will be estimated using the Clopper-Pearson method. Number with clinical benefit (%).

Outcome measures

Outcome measures
Measure	Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions) n=5 Participants Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat Q3W for at least 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo 5 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions) n=11 Participants Patients receive pembrolizumab IV as in Arm A. Patients undergo 3 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction) n=6 Participants Patients receive pembrolizumab IV as in Arm A. Patients undergo 1 SRS fraction between days 2-3 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS
Clinical Benefit (Extra-cranial)	60 Percentage of participants Interval 15.0 to 95.0	55 Percentage of participants Interval 23.0 to 83.0	33 Percentage of participants Interval 4.0 to 78.0

Adverse Events

Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 3 deaths

Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions)

Serious events: 5 serious events

Other events: 10 other events

Deaths: 7 deaths

Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Mohammad K Khan

Emory University

Phone: 404-778-3473

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions) n=6 participants at risk Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat Q3W for at least 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo 5 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions) n=12 participants at risk Patients receive pembrolizumab IV as in Arm A. Patients undergo 3 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction) n=7 participants at risk Patients receive pembrolizumab IV as in Arm A. Patients undergo 1 SRS fraction between days 2-3 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS
Respiratory, thoracic and mediastinal disorders Pleural effusion	16.7% 1/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	16.7% 1/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify - Pulmonary embolism	33.3% 2/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Respiratory, thoracic and mediastinal disorders Respiratory failure	33.3% 2/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Gastrointestinal disorders Nausea	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Gastrointestinal disorders Vomiting	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
General disorders Chills	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
General disorders Fatigue	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
General disorders Fever	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	14.3% 1/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
General disorders Wound Infection	16.7% 1/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Musculoskeletal and connective tissue disorders Chest Wall Pain	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Nervous system disorders Headache	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
General disorders shortness of breath	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Infections and infestations Wound Infection	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Cardiac disorders Palpitations	16.7% 1/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
General disorders Non-cardiac chest pain	16.7% 1/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)

Measure	Experimental: Arm A (Pembrolizumab, 30 Gray (Gy) Over 5 Fractions) n=6 participants at risk Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat Q3W for at least 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo 5 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm B (Pembrolizumab, 27 Gy Over 3 Fractions) n=12 participants at risk Patients receive pembrolizumab IV as in Arm A. Patients undergo 3 SRS fractions between days 2-15 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS	Experimental: Arm C (Pembrolizumab, 18-21 Gy in One Fraction) n=7 participants at risk Patients receive pembrolizumab IV as in Arm A. Patients undergo 1 SRS fraction between days 2-3 of course 1. Pembrolizumab: Given IV Stereotactic Radiosurgery: Undergo SRS
Eye disorders Periorbital edema	16.7% 1/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Gastrointestinal disorders Diarrhea	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Gastrointestinal disorders Constipation	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
General disorders Pain	16.7% 1/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Investigations Platelet count decreased	16.7% 1/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Investigations White blood cell decreased	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Metabolism and nutrition disorders Hypoglycemia	16.7% 1/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Metabolism and nutrition disorders Hypokalemia	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Psychiatric disorders Agitation	16.7% 1/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Skin and subcutaneous tissue disorders Radiation dermatitis	16.7% 1/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Skin and subcutaneous tissue disorders Dermatitis, other	16.7% 1/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Nervous system disorders Symptomatic radionecrosis	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	16.7% 2/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	14.3% 1/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Gastrointestinal disorders Nausea	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Nervous system disorders Headache	33.3% 2/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)
Nervous system disorders Extremity Numbness	0.00% 0/6 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	8.3% 1/12 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)	0.00% 0/7 • Serious and Other Adverse Events assessed for 15 months, mortality assessed up to 3 years)