Trial Outcomes & Findings for Ipilimumab, Nivolumab, and Radiation Therapy in Treating Patients With HPV Positive Advanced Oropharyngeal Squamous Cell Carcinoma (NCT NCT03799445)

Last Updated: 2026-04-30

Results Overview

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter with an absolute increase of at least 5 mm or the appearance of new lesions

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

6 months post completion of radiation therapy (approximately 9 months post start of treatment)

Results posted on

2026-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental (Ipi/Nivo) 2 6-week cycles of IV ipilimumab (1 mg/kg day 1) and nivolumab (3 mg/kg day 1, 15, 29) + concurrent intensity-modulated RT cycle 2 (5 days/wk, 6 wks)
Overall Study STARTED	37
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental (Ipi/Nivo) 2 6-week cycles of IV ipilimumab (1 mg/kg day 1) and nivolumab (3 mg/kg day 1, 15, 29) + concurrent intensity-modulated RT cycle 2 (5 days/wk, 6 wks)
Overall Study Protocol Violation	1
Overall Study Not eligible	1

Baseline Characteristics

Ipilimumab, Nivolumab, and Radiation Therapy in Treating Patients With HPV Positive Advanced Oropharyngeal Squamous Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental (Ipi/Nivo) n=35 Participants 2 6-week cycles of IV ipilimumab (1 mg/kg day 1) and nivolumab (3 mg/kg day 1, 15, 29) + concurrent intensity-modulated RT cycle 2 (5 days/wk, 6 wks)
Age, Categorical <=18 years	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=14 Participants
Age, Categorical >=65 years	15 Participants n=14 Participants
Sex: Female, Male Female	1 Participants n=14 Participants
Sex: Female, Male Male	34 Participants n=14 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=14 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=14 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants
Race (NIH/OMB) Asian	0 Participants n=14 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants
Race (NIH/OMB) Black or African American	1 Participants n=14 Participants
Race (NIH/OMB) White	33 Participants n=14 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=14 Participants
Region of Enrollment United States	35 participants n=14 Participants
Distribution of categorical clinical characteristics among evaluable participants ECOG PS: 0	32 Participants n=14 Participants
Distribution of categorical clinical characteristics among evaluable participants ECOG PS: 1	3 Participants n=14 Participants
Distribution of categorical clinical characteristics among evaluable participants Primary Site: Base of tongue	22 Participants n=14 Participants
Distribution of categorical clinical characteristics among evaluable participants Primary Site: Oropharynx, NOS	1 Participants n=14 Participants
Distribution of categorical clinical characteristics among evaluable participants Primary Site: Tonsil	12 Participants n=14 Participants
Distribution of categorical clinical characteristics among evaluable participants Smoking history: Never	15 Participants n=14 Participants
Distribution of categorical clinical characteristics among evaluable participants Smoking history: Former	11 Participants n=14 Participants
Distribution of categorical clinical characteristics among evaluable participants Smoking history: Current	9 Participants n=14 Participants
Distribution of categorical clinical characteristics among evaluable participants Overall Stage: Stage I	33 Participants n=14 Participants
Distribution of categorical clinical characteristics among evaluable participants Overall Stage: Stage II	2 Participants n=14 Participants

PRIMARY outcome

Timeframe: 6 months post completion of radiation therapy (approximately 9 months post start of treatment)

Outcome measures

Outcome measures
Measure	Experimental (Ipi/Nivo) n=35 Participants 2 6-week cycles of IV ipilimumab (1 mg/kg day 1) and nivolumab (3 mg/kg day 1, 15, 29) + concurrent intensity-modulated RT cycle 2 (5 days/wk, 6 wks)
Radiographic (RECIST) Response Partial Response	5 Participants
Radiographic (RECIST) Response Stable Disease	29 Participants
Radiographic (RECIST) Response Progression	1 Participants

PRIMARY outcome

Timeframe: From first registration on trial (baseline biopsy) to post Cycle 1 of IO (6 weeks after start of treatment)

Population: 8 patients had missing follow up viable tumor due to FFPE core missed on treatment (6) and the COVID shutdown (2), so were excluded from analysis.

Pathologic response refers to the evaluation of how much a tumor has shrunk after treatment by the pathologist on trial examining tissue samples under a microscope. Tissue samples from baseline and at follow up were evaluated for tumor response. Percent viable tumor change is calculated using viable tumor data collected at the biopsy to the biopsy at the end of Cycle 1 of treatment.

Outcome measures

Outcome measures
Measure	Experimental (Ipi/Nivo) n=27 Participants 2 6-week cycles of IV ipilimumab (1 mg/kg day 1) and nivolumab (3 mg/kg day 1, 15, 29) + concurrent intensity-modulated RT cycle 2 (5 days/wk, 6 wks)
Pathologic Response -- Percent Viable Tumor Change	-67.3 percent of viable tumor change Standard Deviation 28.3

SECONDARY outcome

Timeframe: time of first drug administration to 30 days after last drug administration

Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines. All AEs, whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy

Outcome measures

Outcome measures
Measure	Experimental (Ipi/Nivo) n=35 Participants 2 6-week cycles of IV ipilimumab (1 mg/kg day 1) and nivolumab (3 mg/kg day 1, 15, 29) + concurrent intensity-modulated RT cycle 2 (5 days/wk, 6 wks)
Toxicity (Number of Adverse Events) Grade 4, Definite	0 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 4, Probable	0 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 4, Possible	3 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 4, Unlikely	0 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 4, Unrelated	0 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 3, Definite	19 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 3, Probable	11 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 3, Possible	16 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 3, Unlikely	2 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 3, Unrelated	5 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 2, Definite	76 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 2, Probable	42 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 2, Possible	80 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 2, Unlikely	10 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 2, Unrelated	17 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 1, Definite	110 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 1, Probable	69 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 1, Possible	253 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 1, Unlikely	38 Number of AEs/incidents
Toxicity (Number of Adverse Events) Grade 1, Unrelated	75 Number of AEs/incidents

SECONDARY outcome

Timeframe: 12 month post treatment follow up (15 months post treatment start), 18 month post treatment follow up (21 months post treatment start), 24 month post treatment follow up (27 months post treatment start)

Analyses of overall survival (OS) and progression-free survival (PFS) were performed. PFS was defined as from treatment initiation to progression or death, whichever occurred first, or last follow-up. The distribution was estimated by Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Experimental (Ipi/Nivo) n=35 Participants 2 6-week cycles of IV ipilimumab (1 mg/kg day 1) and nivolumab (3 mg/kg day 1, 15, 29) + concurrent intensity-modulated RT cycle 2 (5 days/wk, 6 wks)
Survival Analysis -- Progression Free Survival 12 month	93.8 percentage of participants Interval 85.7 to 100.0
Survival Analysis -- Progression Free Survival 18 month	87.5 percentage of participants Interval 76.8 to 99.0
Survival Analysis -- Progression Free Survival 24 month	84.4 percentage of participants Interval 72.7 to 97.9

SECONDARY outcome

Analyses of overall survival (OS) and progression-free survival (PFS) were performed. OS was defined as from treatment initiation to death or last follow-up time. The distribution was estimated by Kaplan-Meier method. No death was observed.

Outcome measures

Outcome measures
Measure	Experimental (Ipi/Nivo) n=35 Participants 2 6-week cycles of IV ipilimumab (1 mg/kg day 1) and nivolumab (3 mg/kg day 1, 15, 29) + concurrent intensity-modulated RT cycle 2 (5 days/wk, 6 wks)
Survival Analysis -- Overall Survival (Percentage of Participants Alive at 12 Months, 18 Months, and 24 Months) 12 month	100 percentage of participants
Survival Analysis -- Overall Survival (Percentage of Participants Alive at 12 Months, 18 Months, and 24 Months) 18 month	100 percentage of participants
Survival Analysis -- Overall Survival (Percentage of Participants Alive at 12 Months, 18 Months, and 24 Months) 24 month	100 percentage of participants

Adverse Events

Experimental (Ipi/Nivo)

Serious events: 9 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Experimental (Ipi/Nivo) n=35 participants at risk 2 6-week cycles of IV ipilimumab (1 mg/kg day 1) and nivolumab (3 mg/kg day 1, 15, 29) + concurrent intensity-modulated RT cycle 2 (5 days/wk, 6 wks)
General disorders Adrenal insufficiency	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Myositis	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Dehydration	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Hyponatremia	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	8.6% 3/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Dysphagia	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Neck pain	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Anorexia	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Suicidal ideation	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Diabetic ketoacidosis	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Nervous system disorders Encephalopathy	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.

Other adverse events

Other adverse events
Measure	Experimental (Ipi/Nivo) n=35 participants at risk 2 6-week cycles of IV ipilimumab (1 mg/kg day 1) and nivolumab (3 mg/kg day 1, 15, 29) + concurrent intensity-modulated RT cycle 2 (5 days/wk, 6 wks)
Gastrointestinal disorders Abdominal discomfort	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Abdominal pain	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Actinic keratosis, left face	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Renal and urinary disorders Acute kidney injury	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Adjustment disorder (anxiety mixed with depression)	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Adrenal insufficiency	8.6% 3/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Nervous system disorders Aguesia (altered/no taste)	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Alanine aminotransferase increased	54.3% 19/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Alkaline phosphatase increased	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Alopecia	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Nervous system disorders Altered smell	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Amylase increased	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Amylase decreased	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Blood and lymphatic system disorders Anemia	25.7% 9/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Anorexia	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Anxiety	8.6% 3/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Appetite change	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Arthralgia	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Arthralgic stiffness (Both shoulders)	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Aspartate aminotransferase increased	31.4% 11/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Nervous system disorders Ataxia	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations BUN increased	14.3% 5/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Back pain	8.6% 3/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Bleeding mouth ulcers	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Blisters on lower gums	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Bloating	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Blood bilirubin increased	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Respiratory, thoracic and mediastinal disorders Blood in sputum	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Blood/mucus in stool	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Blurred vision	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Cold intolerance	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Colitis	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Conjunctivitis	8.6% 3/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Constipation	37.1% 13/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Respiratory, thoracic and mediastinal disorders Cough	8.6% 3/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Creatinine increased	42.9% 15/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Decreased appetite	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Nervous system disorders Decreased smell	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Dehydration	48.6% 17/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Dermatitis radiation	82.9% 29/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Diarrhea	17.1% 6/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Nervous system disorders Dizziness	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Dry eye	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Dry mouth	85.7% 30/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Dry skin	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Nervous system disorders Dysgeusia	100.0% 35/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Dysphagia/Odynophagia	94.3% 33/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.6% 3/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Ear pain	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Emotional lability	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Blood and lymphatic system disorders Eosinophilia	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Erythema multiforme	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Erythematous papules, forehead	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Eyelid function disorder	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Fatigue	100.0% 35/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Fever	17.1% 6/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Folliculitis, razor induced	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Free T3 increased	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Free T4 decreased	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Generalized edema	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Nervous system disorders Headache	14.3% 5/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Heartburn	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Hemoglobin decreased	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Hypercalcemia	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Hyperglycemia	14.3% 5/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Hyperkalemia	11.4% 4/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Hypermagnesemia	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Hypernatremia	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Hyperthyroidism	14.3% 5/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Vascular disorders Hypertension	37.1% 13/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Hypoalbuminemia	11.4% 4/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Hypocalcemia	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Hypoglycemia	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Hypokalemia	8.6% 3/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Hyponatremia	42.9% 15/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Metabolism and nutrition disorders Hypophosphatemia	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Vascular disorders Hypotension	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Hypothyroidism	51.4% 18/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Infusion related reaction	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Insomnia	8.6% 3/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Itchiness on back of head and lower back	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Joint effusion	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Joint pain	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Knee pain	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations LDH increased	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Left hip pain	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Nervous system disorders Lethargy	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Nervous system disorders Light headedness	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Lipase increased	54.3% 19/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Loose stool	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Vascular disorders Lymphedema	22.9% 8/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Lymphocyte count decreased	77.1% 27/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Infections and infestations Mild Thrush	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Mouth sore	11.4% 4/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Mucositis (tongue, throat, mouth)	100.0% 35/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Mucous secretion increased	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Myalgia	8.6% 3/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Myositis	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Nausea	62.9% 22/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Neck edema	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Neck pain	8.6% 3/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Nervous system disorders Numbness (Right Hand)	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Oral Mucositis	8.6% 3/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Oral dysesthesia	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Infections and infestations Oral thrush	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Oropharyngeal Candidiasis	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Cardiac disorders Orthostatic hypotension	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Pain (tongue, mouth, throat)	100.0% 35/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Pain of skin	8.6% 3/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Palmar-Plantar	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Pancreatitis	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Papulopustular rash	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Renal and urinary disorders Proteinuria	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Pruritus	37.1% 13/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Rash (cheek & posterior neck)	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Rash acneiform	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Rash maculo-papular	62.9% 22/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Rash palmar-plantar	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Red eyes with occasional itching	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Redness, neck area	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Seborrheic keratosis, LLE	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Serum amylase increased	82.9% 29/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Cardiac disorders Sinus tachycardia	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Infections and infestations Sinusitis	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Respiratory, thoracic and mediastinal disorders Sore throat	40.0% 14/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Stomach pain	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Swallow pain	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Swelling right cervical nodes	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Blood and lymphatic system disorders Swelling right nodes	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Nervous system disorders Syncope	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations T4 decreased	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations TSH decreased	8.6% 3/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Telangiectasia	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Thick mucous secretions	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Infections and infestations Thrush	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Thyroiditis	5.7% 2/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Tooth discoloration	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Musculoskeletal and connective tissue disorders Trismus	14.3% 5/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Ulcer on left lateral tongue	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Ulceration on right side of tongue	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Respiratory, thoracic and mediastinal disorders Upper Airway inflammation	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Renal and urinary disorders Urinary frequency	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Skin and subcutaneous tissue disorders Urticaria	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Gastrointestinal disorders Vomiting	14.3% 5/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations WBC increased	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
General disorders Watering eyes	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations Weight loss	100.0% 35/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations White blood cell decreased	22.9% 8/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.
Investigations eGFR decreased	2.9% 1/35 • first administration of investigational agent to 30 days following last dose of study drug (approximately 4 months post first administration) Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines.

Additional Information

Dr. Renata Ferrarotto

The University of Texas MD Anderson Cancer Center

Phone: (713) 745-6774

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place