Trial Outcomes & Findings for Cisplatin and Gemcitabine Hydrochloride With or Without Berzosertib in Treating Patients With Metastatic Urothelial Cancer (NCT NCT02567409)

NCT ID: NCT02567409

Last Updated: 2025-03-03

Results Overview

Estimated using the product-limit method of Kaplan and Meier. Event defined as progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 87 participants
• Primary outcome timeframe: Day of randomization, until progression, or death, assessed up to 12 months
• Results posted on: 2025-03-03

Participant Flow

Participant milestones

Measure	Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin) Patients receive cisplatin, 60 mg/m2, on day 1; gemcitabine, 875 mg/m2, on days 1 and 8; and berzosertib, 90 mg/m2, on days 2 and 9 of a 21-day cycle. Berzosertib: Given IV Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV	Arm B (Gemcitabine Hydrochloride, Cisplatin) Patients receive cisplatin,70 mg/m2, on day 1 and gemcitabine, 1000 mg/m2, on days 1 and 8 of a 21-day cycle Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
Overall Study STARTED	46	41
Overall Study COMPLETED	46	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cisplatin and Gemcitabine Hydrochloride With or Without Berzosertib in Treating Patients With Metastatic Urothelial Cancer

Baseline characteristics by cohort

Measure	Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin) n=46 Participants Patients receive cisplatin, 60 mg/m2, on day 1; gemcitabine, 875 mg/m2, on days 1 and 8; and berzosertib, 90 mg/m2, on days 2 and 9 of a 21-day cycle. Berzosertib: Given IV Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV	Arm B (Gemcitabine Hydrochloride, Cisplatin) n=41 Participants Patients receive cisplatin,70 mg/m2, on day 1 and gemcitabine, 1000 mg/m2, on days 1 and 8 of a 21-day cycle Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV	Total n=87 Participants Total of all reporting groups
Age, Continuous	67.5 years n=5 Participants	65 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	30 Participants n=7 Participants	68 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White Not Hispanic	38 Participants n=5 Participants	34 Participants n=7 Participants	72 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	41 participants n=7 Participants	87 participants n=5 Participants
Prior Neoadjuvant Cisplatin Yes	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Prior Neoadjuvant Cisplatin No	41 Participants n=5 Participants	37 Participants n=7 Participants	78 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of randomization, until progression, or death, assessed up to 12 months

Estimated using the product-limit method of Kaplan and Meier. Event defined as progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Measure	Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin) n=46 Participants Patients receive cisplatin, 60 mg/m2, on day 1; gemcitabine, 875 mg/m2, on days 1 and 8; and berzosertib, 90 mg/m2, on days 2 and 9 of a 21-day cycle. Berzosertib: Given IV Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV	Arm B (Gemcitabine Hydrochloride, Cisplatin) n=41 Participants Patients receive cisplatin,70 mg/m2, on day 1 and gemcitabine, 1000 mg/m2, on days 1 and 8 of a 21-day cycle Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
Progression-free Survival (PFS)	8.0 Months Interval 6.0 to 14.4	8.0 Months Interval 6.8 to NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

SECONDARY outcome

Timeframe: Up to 36 months

Estimated using the product-limit method of Kaplan and Meier. Event defined as death from any cause.

Outcome measures

Measure	Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin) n=46 Participants Patients receive cisplatin, 60 mg/m2, on day 1; gemcitabine, 875 mg/m2, on days 1 and 8; and berzosertib, 90 mg/m2, on days 2 and 9 of a 21-day cycle. Berzosertib: Given IV Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV	Arm B (Gemcitabine Hydrochloride, Cisplatin) n=41 Participants Patients receive cisplatin,70 mg/m2, on day 1 and gemcitabine, 1000 mg/m2, on days 1 and 8 of a 21-day cycle Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
Overall Survival (OS)	14.4 Months Interval 10.0 to NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	19.8 Months Interval 14.8 to NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

SECONDARY outcome

Timeframe: Up to 36 months

Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Confirmed Objective Response = CR + PR.

Outcome measures

Measure	Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin) n=46 Participants Patients receive cisplatin, 60 mg/m2, on day 1; gemcitabine, 875 mg/m2, on days 1 and 8; and berzosertib, 90 mg/m2, on days 2 and 9 of a 21-day cycle. Berzosertib: Given IV Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV	Arm B (Gemcitabine Hydrochloride, Cisplatin) n=41 Participants Patients receive cisplatin,70 mg/m2, on day 1 and gemcitabine, 1000 mg/m2, on days 1 and 8 of a 21-day cycle Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
Confirmed Objective Response Rate	54 percentage of participants Interval 39.0 to 69.0	63 percentage of participants Interval 47.0 to 78.0

SECONDARY outcome

Timeframe: Assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months.

Adverse events that were fatal or led to treatment discontinuation.

Outcome measures

Measure	Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin) n=46 Participants Patients receive cisplatin, 60 mg/m2, on day 1; gemcitabine, 875 mg/m2, on days 1 and 8; and berzosertib, 90 mg/m2, on days 2 and 9 of a 21-day cycle. Berzosertib: Given IV Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV	Arm B (Gemcitabine Hydrochloride, Cisplatin) n=41 Participants Patients receive cisplatin,70 mg/m2, on day 1 and gemcitabine, 1000 mg/m2, on days 1 and 8 of a 21-day cycle Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
Treatment Limiting Adverse Events Vomiting	0 Participants	1 Participants
Treatment Limiting Adverse Events Hypotension	0 Participants	1 Participants
Treatment Limiting Adverse Events Multi-organ failure	0 Participants	1 Participants
Treatment Limiting Adverse Events Cardiac arrest	1 Participants	0 Participants
Treatment Limiting Adverse Events Neutropenia	2 Participants	0 Participants
Treatment Limiting Adverse Events Respiratory failure	1 Participants	0 Participants
Treatment Limiting Adverse Events Pulmonary embolism	1 Participants	1 Participants
Treatment Limiting Adverse Events Thrombocytopenia	2 Participants	2 Participants
Treatment Limiting Adverse Events Creatinine Increased	1 Participants	2 Participants
Treatment Limiting Adverse Events Leukocytosis	1 Participants	0 Participants
Treatment Limiting Adverse Events Acute kidney injury	1 Participants	0 Participants
Treatment Limiting Adverse Events Urinary tract infection	1 Participants	0 Participants

Adverse Events

Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin)

Serious events: 29 serious events

Other events: 40 other events

Deaths: 29 deaths

Arm B (Gemcitabine Hydrochloride, Cisplatin)

Serious events: 12 serious events

Other events: 31 other events

Deaths: 25 deaths

Serious adverse events

Measure	Arm A (Berzosertib, Gemcitabine Hydrochloride, Cisplatin) n=46 participants at risk Patients receive cisplatin, 60 mg/m2, on day 1; gemcitabine, 875 mg/m2, on days 1 and 8; and berzosertib, 90 mg/m2, on days 2 and 9 of a 21-day cycle. Berzosertib: Given IV Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV	Arm B (Gemcitabine Hydrochloride, Cisplatin) n=41 participants at risk Patients receive cisplatin,70 mg/m2, on day 1 and gemcitabine, 1000 mg/m2, on days 1 and 8 of a 21-day cycle Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
Blood and lymphatic system disorders Anemia	30.4% 14/46 • Number of events 23 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Cardiac arrest	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	4.3% 2/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Multi-organ failure	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Lung infection	6.5% 3/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Pyuria	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Scrotal infection	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sepsis	6.5% 3/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Soft tissue infection	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Urinary tract infection	10.9% 5/46 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Hip fracture	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	8.7% 4/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	19.6% 9/46 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	32.6% 15/46 • Number of events 28 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	13.0% 6/46 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	8.7% 4/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	8.7% 4/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Metabolic Acidosis	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Generalized muscle weakness	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Disease progression	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Syncope	8.7% 4/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Nephrostomy Tube Malfunction	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Acute kidney injury	6.5% 3/46 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 tract obstruction	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Pelvic pain	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 prostatic abscess	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Hypoxia	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Pulmonary edema	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Respiratory failure	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Rash maculo-papular	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thromboembolic event	6.5% 3/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Heart Failure	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 (Berzosertib, Gemcitabine Hydrochloride, Cisplatin) n=46 participants at risk Patients receive cisplatin, 60 mg/m2, on day 1; gemcitabine, 875 mg/m2, on days 1 and 8; and berzosertib, 90 mg/m2, on days 2 and 9 of a 21-day cycle. Berzosertib: Given IV Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV	Arm B (Gemcitabine Hydrochloride, Cisplatin) n=41 participants at risk Patients receive cisplatin,70 mg/m2, on day 1 and gemcitabine, 1000 mg/m2, on days 1 and 8 of a 21-day cycle Cisplatin: Given IV Gemcitabine Hydrochloride: Given IV
Blood and lymphatic system disorders Anemia	78.3% 36/46 • Number of events 262 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	63.4% 26/41 • Number of events 193 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Blood LDH Increased	2.2% 1/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Blood LDH increased	2.2% 1/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Febrile neutropenia	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Increased WBC count	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Left groin mass oozing	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	4.3% 2/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Thrombotic thrombocytopenic purpura	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 WBC count increased	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 thrombocytosis	2.2% 1/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrial fibrillation	4.3% 2/46 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrioventricular block first degree	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Chest pain - cardiac	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Palpitations	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus bradycardia	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	13.0% 6/46 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Supraventricular tachycardia	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Ear pain	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Hearing impaired	4.3% 2/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.8% 4/41 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Tinnitus	8.7% 4/46 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.2% 5/41 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Blurred vision	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Right eye vision	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Visual acuity decreased	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders right eye vision	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal distension	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	17.4% 8/46 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.1% 7/41 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Anal hemorrhage	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Bloating	2.2% 1/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	26.1% 12/46 • Number of events 32 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	39.0% 16/41 • Number of events 47 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	23.9% 11/46 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.0% 9/41 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diverticulosis	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	4.3% 2/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	2.2% 1/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	4.3% 2/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophagitis	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gas pain	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.6% 6/41 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Hemorrhoids	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mouth Sores	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.8% 4/41 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	63.0% 29/46 • Number of events 101 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	56.1% 23/41 • Number of events 104 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral dysesthesia	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral pain	2.2% 1/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Sore tongue	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Stomach pain	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Toothache	2.2% 1/46 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Viral gastroenteritis	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	23.9% 11/46 • Number of events 25 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.6% 15/41 • Number of events 31 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders hematochezia	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders indegestion	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders mouth sores	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chattering teeth without chills	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	13.0% 6/46 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema face	4.3% 2/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	23.9% 11/46 • Number of events 37 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.6% 6/41 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	56.5% 26/46 • Number of events 114 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	63.4% 26/41 • Number of events 121 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	23.9% 11/46 • Number of events 15 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.8% 4/41 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	4.3% 2/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Gait disturbance	4.3% 2/46 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Generalized edema	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Hypoproteinemia	8.7% 4/46 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Hyporteinemia	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Increased Blood Urea	4.3% 2/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders IncreasedBlood urea	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	13.0% 6/46 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Infusion site extravasation	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Injection site reaction	6.5% 3/46 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders LDH level	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Localized edema	2.2% 1/46 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Lump to back of neck	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Malaise	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Non-cardiac chest pain	2.2% 1/46 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	17.4% 8/46 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Raised Blood Urea	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Redness around Infusion site	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Right Nipple Sensation Intermittent	2.2% 1/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Weakness	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders diaphoresis	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders edema of limb	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders functional status decline	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders pain at infusion site	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders pain at portal site	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders right nipple sensation intermittent	2.2% 1/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	4.3% 2/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders cold sores	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Cold Symptoms	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Cold symptoms	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Gum infection	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Herpes zoster	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Leaking left inguinal area from tumor si	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Lung infection	6.5% 3/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Papulopustular rash	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Rash pustular	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sepsis of unknown origin	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sinusitis	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	6.5% 3/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Thrush	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Tooth infection	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper respiratory infection	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Urinary Tract Infection	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Urinary tract infection	15.2% 7/46 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.6% 6/41 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations ear infection	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	10.9% 5/46 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Burn	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Cut on Finger	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	8.7% 4/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Skin Tear	2.2% 1/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 firmness of vein in left arm	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 firmness of vein in right arm	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 firmness, swelling of vein on back of ri	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 firmness/swelling of vein on back of rig	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 knot in left arm distal to elbow	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations AST, decreased	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	17.4% 8/46 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.0% 9/41 • Number of events 19 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	26.1% 12/46 • Number of events 39 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.7% 13/41 • Number of events 48 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	19.6% 9/46 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	19.5% 8/41 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood Lactate Dehydrogenase Increased	2.2% 1/46 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood Lactate Dehydrogenase increased	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood bicarbonate decreased	2.2% 1/46 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood bilirubin increased	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood lactate dehydrogenase increased	4.3% 2/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Cardiac troponin I increased	2.2% 1/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Cardiac troponin T increased	2.2% 1/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	41.3% 19/46 • Number of events 67 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	41.5% 17/41 • Number of events 83 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Glucosuria	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperphosphatemia	6.5% 3/46 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Increased Blood urea	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Increased LDH	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Increased Lactic Dehdrogenase	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations IncreasedLDH	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations IncreasedPhosphate	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Inreased LDH	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations LDH increased	8.7% 4/46 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lactate Dehydrogenase Increased	2.2% 1/46 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lactic acid increased	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	30.4% 14/46 • Number of events 94 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	34.1% 14/41 • Number of events 60 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	50.0% 23/46 • Number of events 78 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	48.8% 20/41 • Number of events 55 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Phosphorus Increased	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	73.9% 34/46 • Number of events 212 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	56.1% 23/41 • Number of events 162 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Procalcitonin, increased	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Reduced Bicarbonate	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	4.3% 2/46 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	17.4% 8/46 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.1% 7/41 • Number of events 29 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	41.3% 19/46 • Number of events 88 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.6% 15/41 • Number of events 56 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations hyperphosphatemia	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations hypoproteinemia	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Acidosis	2.2% 1/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	23.9% 11/46 • Number of events 31 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	24.4% 10/41 • Number of events 44 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders DECREASED ALT	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders DECREASED AST	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	15.2% 7/46 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.1% 7/41 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	19.6% 9/46 • Number of events 28 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	26.8% 11/41 • Number of events 35 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	17.4% 8/46 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.6% 6/41 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypermagnesemia	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperuricemia	2.2% 1/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	30.4% 14/46 • Number of events 49 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	24.4% 10/41 • Number of events 39 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	21.7% 10/46 • Number of events 23 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	34.1% 14/41 • Number of events 38 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	4.3% 2/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	21.7% 10/46 • Number of events 35 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	26.8% 11/41 • Number of events 40 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypomagnesemia	28.3% 13/46 • Number of events 28 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	24.4% 10/41 • Number of events 30 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	45.7% 21/46 • Number of events 59 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	48.8% 20/41 • Number of events 59 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	23.9% 11/46 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	24.4% 10/41 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Increased ALT	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Increased AST	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Raised LDH	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Vitamin D decreased	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders vitamin D deficiency	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Arthralgia	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	15.2% 7/46 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.6% 6/41 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	10.9% 5/46 • Number of events 15 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Calf tenderness	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Generalized muscle weakness	19.6% 9/46 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.6% 6/41 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Gout	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Hip pain	2.2% 1/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	10.9% 5/46 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.8% 4/41 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Osteoarthritis	2.2% 1/46 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	6.5% 3/46 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.6% 6/41 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Pulled muscle	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Umbiliclal hernia	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Altered Mental status	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Disorientation	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	19.6% 9/46 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	24.4% 10/41 • Number of events 15 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dysarthria	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dysgeusia	13.0% 6/46 • Number of events 27 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.6% 6/41 • Number of events 22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Encephalopathy	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Extrapyramidal disorder	2.2% 1/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	10.9% 5/46 • Number of events 23 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.1% 7/41 • Number of events 23 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Paresthesia	15.2% 7/46 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	10.9% 5/46 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.2% 5/41 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Presyncope	4.3% 2/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Stroke	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Tremor	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	8.7% 4/46 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	4.3% 2/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	6.5% 3/46 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	13.0% 6/46 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.2% 5/41 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Vivid dreams	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Acute kidney injury	6.5% 3/46 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Bladder spasm	2.2% 1/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Chronic kidney disease	8.7% 4/46 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Cystitis noninfective	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	10.9% 5/46 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.8% 4/41 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hydronephrosis	6.5% 3/46 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Neph Tube not draining	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Nephrostomy tube malfunction	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Nocturia	4.3% 2/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	6.5% 3/46 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.8% 4/41 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Renal insufficiency	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 retention	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 tract obstruction	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 tract pain	2.2% 1/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 urgency	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Pelvic pain	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Perineal pain	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Scrotal pain	2.2% 1/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Vaginal pain	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Allergic rhinitis	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Aspiration	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 BILATERAL LOWER LUNG RALES	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	17.4% 8/46 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.8% 4/41 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	23.9% 11/46 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.2% 5/41 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Epistaxis	6.5% 3/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.8% 4/41 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Hemoptysis	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Hiccups	8.7% 4/46 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.2% 5/41 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Hypoxia	4.3% 2/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	10.9% 5/46 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Productive cough	4.3% 2/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Pulmonary fibrosis	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Rhinorrhea	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Sneezing	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	6.5% 3/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.3% 3/41 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Wheezing	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 dry mucus membranes with blood mixed int	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Callus	2.2% 1/46 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Facial Petechia	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Hyperhidrosis	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Itching	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Melanoma	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Pain of skin	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Pruritus	4.3% 2/46 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 RIGHT WRIST ECCHYMOSIS	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Rash NOS	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Rash NOS (Leg Petechia)	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Rash acneiform	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Rash maculo-papular	6.5% 3/46 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.9% 2/41 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Rash over back and abdomen	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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	2.2% 1/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Skin ulceration	2.2% 1/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Tenderness left upper arm	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Tinea crusis (groin)	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 Urticaria	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 petechiae	2.2% 1/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 seborrheic dermatitis	2.2% 1/46 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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 tinea cruris (groin)	2.2% 1/46 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Surgical and medical procedures Mediport Placement	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders DVT	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hematoma	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hot flashes	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	21.7% 10/46 • Number of events 31 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.0% 9/41 • Number of events 32 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	15.2% 7/46 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Peripheral artery disease	0.00% 0/46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Petechiae	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Phlebitis	10.9% 5/46 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.4% 1/41 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Superficial thrombophlebitis	2.2% 1/46 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thromboembolic event	13.0% 6/46 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	12.2% 5/41 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 36 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

Restriction type: LTE60