Trial Outcomes & Findings for Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer (NCT NCT01807065)

NCT ID: NCT01807065

Last Updated: 2020-08-25

Results Overview

Estimated using the product-limit method of Kaplan and Meier. Progression is defined as one or more of the following: 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesions; PSA increase of 25% from baseline or nadir and by 2ng/uL or greater at 12 weeks; death due to disease without prior documentation of progression and without symptomatic deterioration.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: Until progression or death, Up to 2 years.
• Results posted on: 2020-08-25

Participant Flow

Participant milestones

Measure	Arm A (Sipuleucel-T) Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50. Each dose of sipuleucel-T contains a minimum of 50 million activated CD54+ cells. sipuleucel-T: Given IV laboratory biomarker analysis: Correlative studies	Arm B (Radiation Therapy, Sipuleucel-T) Patients undergo external beam radiation therapy in weeks 1-2. Radiation given in 10 fractions of 300cGy for a total dose of 3000cGy. Patients also receive sipuleucel-T as in Arm A. sipuleucel-T: Given IV external beam radiation therapy: Undergo external beam radiation therapy laboratory biomarker analysis: Correlative studies
Overall Study STARTED	25	26
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Arm A (Sipuleucel-T) Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50. Each dose of sipuleucel-T contains a minimum of 50 million activated CD54+ cells. sipuleucel-T: Given IV laboratory biomarker analysis: Correlative studies	Arm B (Radiation Therapy, Sipuleucel-T) Patients undergo external beam radiation therapy in weeks 1-2. Radiation given in 10 fractions of 300cGy for a total dose of 3000cGy. Patients also receive sipuleucel-T as in Arm A. sipuleucel-T: Given IV external beam radiation therapy: Undergo external beam radiation therapy laboratory biomarker analysis: Correlative studies
Overall Study Receive no sip-T due to IV access	1	1

Baseline Characteristics

Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer

Baseline characteristics by cohort

Measure	Arm A (Sipuleucel-T) n=24 Participants Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50. Each dose of sipuleucel-T contains a minimum of 50 million activated CD54+ cells. sipuleucel-T: Given IV laboratory biomarker analysis: Correlative studies	Arm B (Radiation Therapy, Sipuleucel-T) n=25 Participants Patients undergo external beam radiation therapy in weeks 1-2. Radiation given in 10 fractions of 300cGy for a total dose of 3000cGy. Patients also receive sipuleucel-T as in Arm A. sipuleucel-T: Given IV external beam radiation therapy: Undergo external beam radiation therapy laboratory biomarker analysis: Correlative studies	Total n=49 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	67 years n=7 Participants	67 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	25 participants n=7 Participants	49 participants n=5 Participants
Gleason Score	8 Gleason grading n=5 Participants	7 Gleason grading n=7 Participants	8 Gleason grading n=5 Participants

PRIMARY outcome

Timeframe: Until progression or death, Up to 2 years.

Estimated using the product-limit method of Kaplan and Meier.

Progression is defined as one or more of the following:

20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesions; PSA increase of 25% from baseline or nadir and by 2ng/uL or greater at 12 weeks; death due to disease without prior documentation of progression and without symptomatic deterioration.

Outcome measures

Measure	Arm A (Sipuleucel-T) n=24 Participants Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50. Each dose of sipuleucel-T contains a minimum of 50 million activated CD54+ cells. sipuleucel-T: Given IV laboratory biomarker analysis: Correlative studies	Arm B (Radiation Therapy, Sipuleucel-T) n=25 Participants Patients undergo external beam radiation therapy in weeks 1-2. Radiation given in 10 fractions of 300cGy for a total dose of 3000cGy. Patients also receive sipuleucel-T as in Arm A. sipuleucel-T: Given IV external beam radiation therapy: Undergo external beam radiation therapy laboratory biomarker analysis: Correlative studies
Progression-free Survival	2.46 Months Interval 2.17 to 2.66	3.65 Months Interval 2.76 to 4.86

SECONDARY outcome

Timeframe: Up to 60 weeks

Number of participants with specified adverse event that is grade 2 or above and related to treatment. Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0

Outcome measures

Measure	Arm A (Sipuleucel-T) n=24 Participants Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50. Each dose of sipuleucel-T contains a minimum of 50 million activated CD54+ cells. sipuleucel-T: Given IV laboratory biomarker analysis: Correlative studies	Arm B (Radiation Therapy, Sipuleucel-T) n=25 Participants Patients undergo external beam radiation therapy in weeks 1-2. Radiation given in 10 fractions of 300cGy for a total dose of 3000cGy. Patients also receive sipuleucel-T as in Arm A. sipuleucel-T: Given IV external beam radiation therapy: Undergo external beam radiation therapy laboratory biomarker analysis: Correlative studies
Number of Participants With Grade 2 or Above Adverse Events Grade 2 : Chills	3 participants	0 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 2 : Fatigue	1 participants	2 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 2 : Infusion Reaction	1 participants	1 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 2 : Decreased Lymphocyte Count	1 participants	0 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 2 : Nausea	0 participants	1 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 2 : Pain in Extremity	0 participants	1 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 2 : Anemia	0 participants	1 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 2 : Anorexia	0 participants	1 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 2 : Headache	1 participants	1 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 2 : Hypertension	0 participants	3 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 3 : Chills	0 participants	0 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 3 : Fatigue	0 participants	0 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 3 : Infusion Reaction	0 participants	0 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 3 : Decreased Lymphocyte Count	0 participants	0 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 3 : Nausea	0 participants	0 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 3 : Pain in Extremity	0 participants	0 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 3 : Anemia	0 participants	1 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 3 : Anorexia	0 participants	0 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 3 : Headache	0 participants	0 participants
Number of Participants With Grade 2 or Above Adverse Events Grade 3 : Hypertension	0 participants	0 participants

Adverse Events

Arm A (Sipuleucel-T)

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Arm B (Radiation Therapy, Sipuleucel-T)

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A (Sipuleucel-T) n=25 participants at risk Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50. Each dose of sipuleucel-T contains a minimum of 50 million activated CD54+ cells. sipuleucel-T: Given IV laboratory biomarker analysis: Correlative studies	Arm B (Radiation Therapy, Sipuleucel-T) n=24 participants at risk Patients undergo external beam radiation therapy in weeks 1-2. Radiation given in 10 fractions of 300cGy for a total dose of 3000cGy. Patients also receive sipuleucel-T as in Arm A. sipuleucel-T: Given IV external beam radiation therapy: Undergo external beam radiation therapy laboratory biomarker analysis: Correlative studies
Infections and infestations Skin infection	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hematuria	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Measure	Arm A (Sipuleucel-T) n=25 participants at risk Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50. Each dose of sipuleucel-T contains a minimum of 50 million activated CD54+ cells. sipuleucel-T: Given IV laboratory biomarker analysis: Correlative studies	Arm B (Radiation Therapy, Sipuleucel-T) n=24 participants at risk Patients undergo external beam radiation therapy in weeks 1-2. Radiation given in 10 fractions of 300cGy for a total dose of 3000cGy. Patients also receive sipuleucel-T as in Arm A. sipuleucel-T: Given IV external beam radiation therapy: Undergo external beam radiation therapy laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Anemia	28.0% 7/25 • Number of events 20 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	45.8% 11/24 • Number of events 34 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 3 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus bradycardia	28.0% 7/25 • Number of events 19 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	29.2% 7/24 • Number of events 18 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	12.0% 3/25 • Number of events 3 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Watering eyes	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 3/24 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.8% 5/24 • Number of events 9 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 3 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophagitis	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastritis	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	4.0% 1/25 • Number of events 3 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 3/24 • Number of events 3 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	8.0% 2/25 • Number of events 3 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	29.2% 7/24 • Number of events 13 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral dysesthesia	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	12.0% 3/25 • Number of events 3 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 4/24 • Number of events 5 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Angioectasia	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders dry heaves	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	36.0% 9/25 • Number of events 17 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	48.0% 12/25 • Number of events 22 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	41.7% 10/24 • Number of events 19 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Flu like symptoms	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Infusion related reaction	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 3 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	12.0% 3/25 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 4/24 • Number of events 9 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders Allergic reaction	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Bronchial infection	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations apheresis line infection	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Bruising	4.0% 1/25 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Dermatitis radiation	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 4/24 • Number of events 10 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Fall	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Fracture	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Vascular access complication	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	4.0% 1/25 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	16.0% 4/25 • Number of events 11 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	29.2% 7/24 • Number of events 15 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	12.0% 3/25 • Number of events 5 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 4/24 • Number of events 7 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood bilirubin increased	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	8.0% 2/25 • Number of events 3 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 6 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 3 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	8.0% 2/25 • Number of events 5 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	12.0% 3/25 • Number of events 5 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	29.2% 7/24 • Number of events 20 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	4.0% 1/25 • Number of events 3 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations White blood cell decreased	16.0% 4/25 • Number of events 7 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 3/24 • Number of events 7 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 4/24 • Number of events 7 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperkalemia	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypernatremia	16.0% 4/25 • Number of events 5 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypertriglyceridemia	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 3/24 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	8.0% 2/25 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoglycemia	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 4/24 • Number of events 9 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	4.0% 1/25 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 6 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Obesity	4.0% 1/25 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Back pain	12.0% 3/25 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 6/24 • Number of events 9 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Bone pain	12.0% 3/25 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	4.0% 1/25 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	12.0% 3/25 • Number of events 5 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 6/24 • Number of events 10 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders neck stiffness	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) enlarged thryroid nodule	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) skin lesion	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 3 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) skin lesion - neoplasm benign	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	8.0% 2/25 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Facial muscle weakness	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 6 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	12.0% 3/25 • Number of events 5 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 5 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Paresthesia	4.0% 1/25 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.5% 3/24 • Number of events 7 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Radiculitis	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Tingling face, hands, and feet	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders generalized numbness and tingling during	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders numbness and tingling in right hand	4.0% 1/25 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hematuria	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Proteinuria	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary frequency	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary incontinence	8.0% 2/25 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders decreased force of urinary stream	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 3 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Erectile dysfunction	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Cough	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hoarseness	4.0% 1/25 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.0% 1/25 • Number of events 2 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Postnasal drip	4.0% 1/25 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/24 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders 'mild skin irritation in the posterior r	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Periorbital edema	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Scalp pain	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders contact dermatitis	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hot flashes	0.00% 0/25 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.2% 1/24 • Number of events 1 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	44.0% 11/25 • Number of events 33 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 12/24 • Number of events 35 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	8.0% 2/25 • Number of events 4 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 2/24 • Number of events 3 • Adverse events were collected over a period of 1 year and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-218-5265

Email: pfrankel@coh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place