Trial Outcomes & Findings for Defactinib and VS-6766 for the Treatment of Patients With Metastatic Uveal Melanoma (NCT NCT04720417)

NCT ID: NCT04720417

Last Updated: 2025-07-15

Results Overview

Defined as complete response (CR) + partial response (PR) + stable disease (SD) and determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

From baseline through last follow-up visit (up to 24 months per participant)

Results posted on

2025-07-15

Participant Flow

One subject did not initiate treatment due to rapid disease progression.

Participant milestones

Participant milestones
Measure	Treatment (Defactinib, VS-6766) Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Defactinib, VS-6766) Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy
Overall Study one subject did not initiate treatment due to rapid disease progression	1

Baseline Characteristics

Defactinib and VS-6766 for the Treatment of Patients With Metastatic Uveal Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Defactinib, VS-6766) n=13 Participants Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline through last follow-up visit (up to 24 months per participant)

Population: No subjects met this criteria. The trial was closed before the anticipated accrual of 18 patients, but of the 12 patients that were treated the best overall response rate was 0% as no patient achieved CR or PR. All subjects died or relapsed disease/progression and did not complete.

Defined as complete response (CR) + partial response (PR) + stable disease (SD) and determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Outcome measures

Outcome measures
Measure	Treatment (Defactinib, VS-6766) n=12 Participants Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy	Treatment (Defactinib, VS-6766) - Subjects With Stable Disease Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy
Best Overall Response	0 Participants	—

PRIMARY outcome

Timeframe: From baseline through last follow-up visit (up to 24 months per participant)

Population: The trial was closed before the anticipated accrual of 18 patients, but of the 12 patients that were treated the disease control rate was 50% (6 patients with SD).

Defined as CR+PR+SD and determined by RECIST criteria version 1.1. All estimates of rates will be presented with corresponding 95% exact confidence intervals. For disease control rates, the method of Atkinson and Brown will be used to allow for the two-stage design.

Outcome measures

Outcome measures
Measure	Treatment (Defactinib, VS-6766) n=12 Participants Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy	Treatment (Defactinib, VS-6766) - Subjects With Stable Disease Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy
Disease Control Rate	6 Participants	—

SECONDARY outcome

Timeframe: From first dose of study drug until disease progression or death (whichever occurs first). Up to 24 months per participant.

Population: 12 patients received at least one dose of study drug and were included in progression-free survival (PFS) and follow-up analysis population.

A Kaplan Meier graph and median PFS will be presented overall and by cohort.

Outcome measures

Outcome measures
Measure	Treatment (Defactinib, VS-6766) n=12 Participants Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy	Treatment (Defactinib, VS-6766) - Subjects With Stable Disease Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy
Progression-free Survival (PFS) Progression-Free Survival	3.04 Months Interval 1.91 to 6.15	—
Progression-free Survival (PFS) Follow up period	20 Months Interval 6.77 to 26.8	—

SECONDARY outcome

Timeframe: From first dose of study drug until disease progression or death (whichever occurs first). Up to 14 months.

Population: Trial closed prematurely based on limited clinical activity as reflected by the low rate of short-lasting disease control without any partial responses, slow enrollment, and the heavily pretreated study population reflecting the changing treatment landscape.

A Kaplan Meier graph will be presented overall and by cohort.

Outcome measures

Outcome measures
Measure	Treatment (Defactinib, VS-6766) n=12 Participants Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy	Treatment (Defactinib, VS-6766) - Subjects With Stable Disease Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy
Overall Survival (OS)	2 Participants	—

SECONDARY outcome

Timeframe: From baseline through last follow-up visit (up to 14 months)

Will determine causality of each adverse event to defactinib and VS-6766 and grading severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Estimates of toxicity rates will be presented with corresponding 95% exact confidence intervals. Safety variables will be summarized by descriptive statistics. Laboratory variables will be described using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Adverse events (AEs) will be reported for each dose level and presented as tables of frequency of AEs by body system and by worse severity grade observed.

Outcome measures

Outcome measures
Measure	Treatment (Defactinib, VS-6766) n=12 Participants Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy	Treatment (Defactinib, VS-6766) - Subjects With Stable Disease Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy
Incidence of Adverse Events	43 Number of AEs	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after the last dose of treatment

Population: Analysis not performed. Trial closed prematurely based on limited clinical activity as reflected by the low rate of short-lasting disease control without any partial responses, slow enrollment, and the heavily pretreated study population reflecting the changing treatment landscape.

Tumor samples will be analyzed for changes in tumor metabolic activity.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after the last dose of treatment

Population: 4 total patients with pre- and post- biopsy samples were available. Pre- vs post- biopsy samples was assessed for changes in active ERK (pERK)

Tumor samples will be analyzed for changes in signaling to the ERK pathways. Subjects grouped (Progressive Disease v Stable Disease) for sake of results reporting.

Outcome measures

Outcome measures
Measure	Treatment (Defactinib, VS-6766) n=2 Participants Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy	Treatment (Defactinib, VS-6766) - Subjects With Stable Disease n=2 Participants Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy
Changes in Signaling to the ERK Pathways No change in active ERK (pERK)	2 Participants	0 Participants
Changes in Signaling to the ERK Pathways Reduction in active ERK (pERK)	0 Participants	2 Participants

Adverse Events

Treatment (Defactinib, VS-6766)

Serious events: 5 serious events

Other events: 12 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Defactinib, VS-6766) n=12 participants at risk Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy
Skin and subcutaneous tissue disorders Skin Infection - Grade 3	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Hip dislocation - Grade 3	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Investigations CPK Increased - Grade 3	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Hepatobiliary disorders GGT increased - Grade 3	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Metabolism and nutrition disorders Hypokalemia - Grade 3	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Nervous system disorders Syncope - Grade 3	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Urticaria - Grade 3	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.

Other adverse events

Other adverse events
Measure	Treatment (Defactinib, VS-6766) n=12 participants at risk Patients receive defactinib PO BID and VS-6766 PO BIW (Monday and Thursday or Tuesday and Friday) for 3 weeks in every cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Defactinib Hydrochloride: Given PO Raf/MEK Inhibitor VS-6766: Given PO Biopsy: Undergo tumor biopsy
Gastrointestinal disorders Abdominal bloating - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Acneiform rash - Grade 1	100.0% 12/12 • Number of events 18 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Acneiform rash - Grade 2	33.3% 4/12 • Number of events 4 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Alopecia - Grade 1	8.3% 1/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Alopecia - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Metabolism and nutrition disorders Anorexia - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Eye disorders Blurred Vision - Grade 1	50.0% 6/12 • Number of events 9 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Nervous system disorders Concentration impairment - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Constipation - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Investigations CPK increased - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Investigations CPK increased - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Diarrhea - Grade 1	66.7% 8/12 • Number of events 11 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Diarrhea - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Nervous system disorders Dizziness - Grade 1	41.7% 5/12 • Number of events 5 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Dry Mouth - Grade 1	25.0% 3/12 • Number of events 4 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Dry Skin - Grade 1	41.7% 5/12 • Number of events 7 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Nervous system disorders Dysgeusia - Grade 1	25.0% 3/12 • Number of events 3 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
General disorders Edema - Limbs - Grade 1	41.7% 5/12 • Number of events 8 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
General disorders Edema - Limbs - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
General disorders Fatigue - Grade 1	66.7% 8/12 • Number of events 8 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
General disorders Fatigue - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
General disorders Fever - Grade 1	25.0% 3/12 • Number of events 3 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
General disorders Fever - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders GERD - Grade 1	33.3% 4/12 • Number of events 4 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Hepatobiliary disorders GGT increased - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Respiratory, thoracic and mediastinal disorders Hoarseness - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Maculopapular rash - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Mucositis oral/stomatitis - Grade 1	33.3% 4/12 • Number of events 4 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Nausea - Grade 1	66.7% 8/12 • Number of events 8 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Night Sweats - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Metabolism and nutrition disorders PICA - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Blood and lymphatic system disorders Platelet count decreased - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Eye disorders Pocket of subfoveal fluid right eye - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Maculopapular Rash - Grade 1	25.0% 3/12 • Number of events 3 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Thrush - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Thrush - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Vomiting - Grade 1	25.0% 3/12 • Number of events 3 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Abdominal pain - Grade 1	41.7% 5/12 • Number of events 6 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Endocrine disorders Adrenal insufficiency - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Hepatobiliary disorders Alanine aminotransferase increased - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Metabolism and nutrition disorders Anorexia - Grade 1	16.7% 2/12 • Number of events 3 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Psychiatric disorders Anxiety - Grade 1	41.7% 5/12 • Number of events 5 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Psychiatric disorders Anxiety - Grade 2	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia - Grade 1	41.7% 5/12 • Number of events 6 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Ascites - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Ascites - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Hepatobiliary disorders Aspartate aminotransferase increased - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Back Pain - Grade 1	16.7% 2/12 • Number of events 3 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Back Pain - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Eye disorders Bilateral Myopia - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Bone Spur - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Reproductive system and breast disorders Breast Pain - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Broken nail - left thumb - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Injury, poisoning and procedural complications Bruising - Grade 1	8.3% 1/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Nervous system disorders Burning sensation - Back - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Eye disorders Cataract - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
General disorders Chills - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Investigations Cholesterol high - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Investigations Cholesterol high - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Nervous system disorders Cognitive Disturbance - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Eye disorders Cystoid Macular Edema - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Psychiatric disorders Depression - Grade 1	25.0% 3/12 • Number of events 3 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Eye disorders Dry Eye - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Duodenal Ulcer - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Ear and labyrinth disorders Ear Pain - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
General disorders Edema - Trunk - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Injury, poisoning and procedural complications Fall - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Injury, poisoning and procedural complications Fall - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Injury, poisoning and procedural complications Fracture - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
General disorders Gait Disturbance - Grade 1	8.3% 1/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
General disorders Gait Disturbance - Grade 2	8.3% 1/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Gastritis - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Gastroparesis - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Reproductive system and breast disorders Genital edema - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Eye disorders Glaucoma - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Nervous system disorders Headache - Grade 1	33.3% 4/12 • Number of events 5 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Nervous system disorders Headache - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Cardiac disorders Heart Murmur - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Vascular disorders Hematoma - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Infections and infestations Herpes simplex reactivation - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Hip Dislocation - Grade 2	8.3% 1/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Vascular disorders Hypertension - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Metabolism and nutrition disorders Hypokalemia - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Metabolism and nutrition disorders Hypokalemia - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Vascular disorders Hypotension - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Endocrine disorders Hypothyroidism - Grade 1	33.3% 4/12 • Number of events 4 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Endocrine disorders Hypothyroidism - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Injury, poisoning and procedural complications Injection site reaction - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Psychiatric disorders Insomnia - Grade 1	33.3% 4/12 • Number of events 4 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Congenital, familial and genetic disorders Hereditary Hemochromatosis	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Joint Pain - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Left shoulder nodule - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
General disorders Localized edema - Grade 1	8.3% 1/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Cardiac disorders mitral regurgitation - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Mouth Sores - intermittent - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Muscle Cramp - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Infections and infestations Nail Infection - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Nail Loss - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Renal and urinary disorders Nocturia - Grade 1	25.0% 3/12 • Number of events 3 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Pain - Hip - Grade 1	8.3% 1/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Pain - Hip - Grade 2	8.3% 1/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Pain - Muscle Soreness - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Pain - Shoulder - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Pain - Shoulder - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Paronychia - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Nervous system disorders Peripheral sensory neuropathy - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Respiratory, thoracic and mediastinal disorders Postnasal drip - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Pruritus - Grade 1	33.3% 4/12 • Number of events 4 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary nodules - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Rectal perforation - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Scalp Pain - Grade 1	25.0% 3/12 • Number of events 3 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Scalp Pain - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Cardiac disorders Sinus bradycardia - Grade 1	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Respiratory, thoracic and mediastinal disorders Sinusitis - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Skin abrasion - hand - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Skin discoloration - eye lid - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Infections and infestations Skin infection - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Skin lacerations - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Respiratory, thoracic and mediastinal disorders Sleep Apnea - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders sore bump on left shoulder - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Spinal Fracture - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Gastrointestinal disorders Stomach Pain - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Musculoskeletal and connective tissue disorders Strain (foot) - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Eye disorders Stye - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders subcutaneous tumor removal - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Nervous system disorders Tremor - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
General disorders Tumor Pain - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Infections and infestations Upper respiratory infection - Grade 2	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Renal and urinary disorders Ureteral Polyps - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Infections and infestations Urinary tract infection - Grade 2	16.7% 2/12 • Number of events 2 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.
Skin and subcutaneous tissue disorders Urticaria - Grade 1	8.3% 1/12 • Number of events 1 • From first dose to 28 days after last dose of study drug (approximately 3-14 months) Adverse events (serious and non-serious) were collected from time of informed consent to 28 days after last dose of study drug.

Additional Information

Rino Seedor, MD

Thomas Jefferson University

Phone: 215-955-8874

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place