Trial Outcomes & Findings for Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer (NCT NCT01730833)

NCT ID: NCT01730833

Last Updated: 2025-06-03

Results Overview

Estimated using the product-limit method of Kaplan and Meier. From time of initial treatment until disease progression or death. 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: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 63 participants
• Primary outcome timeframe: assessed up to 5 years
• Results posted on: 2025-06-03

Participant Flow

Participant milestones

Measure	Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors	Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors
Overall Study STARTED	18	45
Overall Study COMPLETED	18	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer

Baseline characteristics by cohort

Measure	Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients n=18 Participants Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors	Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients n=45 Participants Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors	Total n=63 Participants Total of all reporting groups
Age, Continuous	49 years n=5 Participants	56 years n=7 Participants	54 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	45 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	10 Participants n=5 Participants	19 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	5 Participants n=5 Participants	17 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	45 participants n=7 Participants	63 participants n=5 Participants

PRIMARY outcome

Timeframe: assessed up to 5 years

Population: PFS was not performed on the LABC cohort (neoadjuvant patients). A more relevant analysis, Disease-free survival is present elsewhere in these results.

Estimated using the product-limit method of Kaplan and Meier. From time of initial treatment until disease progression or death. 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	Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients n=18 Participants Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors	Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors
Progression Free Survival (MBC Cohort)	22.4 Months Interval 7.1 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.	—

PRIMARY outcome

Timeframe: assessed up to 5 years

Population: Analysis population included LABC participants who achieved pathologic response (pCR). More appropriate PFS analysis for MBC cohort is presented elsewhere in these results.

Estimated using the method of Kaplan-Meier. Disease-free survival is defined as the time from Initial treatment to recurrence of tumor or death

Outcome measures

Measure	Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors	Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients n=29 Participants Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors
Five Year Disease-free Survival (LABC Cohort)	—	96.3 percentage of participants Interval 76.5 to 99.5

SECONDARY outcome

Timeframe: Up to 5 years

Population: Overall response is not appropriate in the neoadjuvant or LABC cohort.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Measure	Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients n=18 Participants Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors	Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors
Overall Response (MBC Cohort)	13 Participants	—

SECONDARY outcome

Timeframe: Assessed up to 5 years

Estimated by the Kaplan-Meier method. From the initial date of treatment to date of death from any cause.

Outcome measures

Measure	Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients n=18 Participants Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors	Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients n=45 Participants Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors
Five Year Overall Survival	54.5 percentage of participants Interval 8.6 to 86.1	94.1 percentage of participants Interval 77.6 to 98.5

Adverse Events

Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients

Serious events: 3 serious events

Other events: 18 other events

Deaths: 8 deaths

Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients

Serious events: 4 serious events

Other events: 45 other events

Deaths: 2 deaths

Serious adverse events

Measure	Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients n=18 participants at risk Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors	Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients n=45 participants at risk Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors
Cardiac disorders Atrial fibrillation	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Blurred vision	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Catheter related infection	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Oth	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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, thoracic and mediastinal di	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thromboembolic event	11.1% 2/18 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Measure	Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients n=18 participants at risk Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors	Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients n=45 participants at risk Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2. Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly. Nab-paclitaxel 100 mg/m2 IV weekly. Treatment is scheduled to continue until: A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.7% 3/45 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.9% 4/45 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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, thoracic and mediastinal di	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Anemia	88.9% 16/18 • Number of events 162 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	88.9% 40/45 • Number of events 172 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Cardiac disorders - Other, specify	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Palpitations	11.1% 2/18 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus bradycardia	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	33.3% 6/18 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	15.6% 7/45 • Number of events 22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Tricuspid valve disease	5.6% 1/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, spe	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Tinnitus	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Vertigo	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Vestibular disorder	5.6% 1/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Blurred vision	27.8% 5/18 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Dry eye	11.1% 2/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.7% 3/45 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Eye disorders - Other, specify	5.6% 1/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.9% 4/45 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Eye pain	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Floaters	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Watering eyes	5.6% 1/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.7% 3/45 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	27.8% 5/18 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	15.6% 7/45 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Bloating	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	44.4% 8/18 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	35.6% 16/45 • Number of events 34 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	55.6% 10/18 • Number of events 29 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	68.9% 31/45 • Number of events 86 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.9% 4/45 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophageal ulcer	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Flatulence	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastritis	5.6% 1/18 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	16.7% 3/18 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 5/45 • Number of events 15 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorders - Other, spec	11.1% 2/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.3% 6/45 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Hemorrhoids	5.6% 1/18 • Number of events 23 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.8% 8/45 • Number of events 22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	27.8% 5/18 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.8% 8/45 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	44.4% 8/18 • Number of events 24 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	62.2% 28/45 • Number of events 68 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral dysesthesia	5.6% 1/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral pain	5.6% 1/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.7% 3/45 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal hemorrhage	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal pain	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Salivary duct inflammation	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Stomach pain	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Toothache	11.1% 2/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	22.2% 4/18 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.2% 10/45 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	5.6% 1/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	15.6% 7/45 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema face	5.6% 1/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	55.6% 10/18 • Number of events 62 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.8% 17/45 • Number of events 39 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Facial pain	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	88.9% 16/18 • Number of events 120 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	95.6% 43/45 • Number of events 183 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	11.1% 2/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 5/45 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Flu like symptoms	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Gait disturbance	11.1% 2/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders General disorders and administration sit	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Infusion related reaction	27.8% 5/18 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	15.6% 7/45 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Injection site reaction	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Irritability	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Localized edema	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Malaise	11.1% 2/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	22.2% 4/18 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.3% 6/45 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders Allergic reaction	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Bladder infection	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Breast infection	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Eye infection	5.6% 1/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Lip infection	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Nail infection	11.1% 2/18 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.3% 6/45 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Otitis externa	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Paronychia	27.8% 5/18 • Number of events 29 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 5/45 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Rash pustular	5.6% 1/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sinusitis	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Tooth infection	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	16.7% 3/18 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	15.6% 7/45 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	11.1% 2/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 5/45 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Vaginal infection	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	22.2% 4/18 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.7% 3/45 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	5.6% 1/18 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Seroma	5.6% 1/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	61.1% 11/18 • Number of events 27 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	48.9% 22/45 • Number of events 79 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	16.7% 3/18 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 9/45 • Number of events 24 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	55.6% 10/18 • Number of events 44 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	35.6% 16/45 • Number of events 62 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood bilirubin increased	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Cholesterol high	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lipase increased	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	11.1% 2/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.9% 4/45 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count increased	5.6% 1/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	44.4% 8/18 • Number of events 29 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.9% 13/45 • Number of events 26 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	16.7% 3/18 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Serum amylase increased	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	11.1% 2/18 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.7% 3/45 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations White blood cell decreased	77.8% 14/18 • Number of events 108 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	60.0% 27/45 • Number of events 80 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	27.8% 5/18 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	15.6% 7/45 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypercalcemia	5.6% 1/18 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.7% 3/45 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypernatremia	22.2% 4/18 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	15.6% 7/45 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	27.8% 5/18 • Number of events 23 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	15.6% 7/45 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	50.0% 9/18 • Number of events 29 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.8% 8/45 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoglycemia	22.2% 4/18 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.9% 4/45 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	27.8% 5/18 • Number of events 15 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	26.7% 12/45 • Number of events 26 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	27.8% 5/18 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	35.6% 16/45 • Number of events 33 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	11.1% 2/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.8% 8/45 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Oth	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Obesity	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 5/45 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	11.1% 2/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	15.6% 7/45 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	16.7% 3/18 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.7% 3/45 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	11.1% 2/18 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue di	11.1% 2/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	38.9% 7/18 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.9% 4/45 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Neck pain	5.6% 1/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	11.1% 2/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.8% 8/45 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecif	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	22.2% 4/18 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Cognitive disturbance	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	16.7% 3/18 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.7% 3/45 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dysgeusia	11.1% 2/18 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.9% 13/45 • Number of events 31 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	33.3% 6/18 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	15.6% 7/45 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Nervous system disorders - Other, specif	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Paresthesia	11.1% 2/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.9% 4/45 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	83.3% 15/18 • Number of events 104 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	80.0% 36/45 • Number of events 150 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Spasticity	11.1% 2/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	22.2% 4/18 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.8% 8/45 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	16.7% 3/18 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.9% 4/45 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	33.3% 6/18 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.8% 8/45 • Number of events 22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Psychiatric disorders - Other, specify	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Restlessness	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hematuria	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Proteinuria	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	5.6% 1/18 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Breast pain	11.1% 2/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 5/45 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Irregular menstruation	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Menorrhagia	11.1% 2/18 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Reproductive system and breast disorders	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 dryness	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.7% 3/45 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	16.7% 3/18 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.7% 3/45 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	33.3% 6/18 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.2% 10/45 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	22.2% 4/18 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	22.2% 4/18 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 9/45 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	11.1% 2/18 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.3% 6/45 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	22.2% 4/18 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.9% 4/45 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	66.7% 12/18 • Number of events 73 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	35.6% 16/45 • Number of events 42 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Dry skin	22.2% 4/18 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.2% 10/45 • Number of events 22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Erythema multiforme	5.6% 1/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Nail discoloration	27.8% 5/18 • Number of events 37 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 15/45 • Number of events 38 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Nail loss	11.1% 2/18 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.7% 3/45 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	16.7% 3/18 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.7% 3/45 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndro	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Periorbital edema	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Photosensitivity	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	27.8% 5/18 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.2% 10/45 • Number of events 19 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	50.0% 9/18 • Number of events 46 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	53.3% 24/45 • Number of events 78 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	16.7% 3/18 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	24.4% 11/45 • Number of events 24 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 and subcutaneous tissue disorders -	44.4% 8/18 • Number of events 30 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.9% 13/45 • Number of events 30 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 hyperpigmentation	44.4% 8/18 • Number of events 43 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	26.7% 12/45 • Number of events 34 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 hypopigmentation	5.6% 1/18 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.4% 2/45 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hot flashes	11.1% 2/18 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.3% 6/45 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	77.8% 14/18 • Number of events 122 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	64.4% 29/45 • Number of events 148 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	5.6% 1/18 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.9% 4/45 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Lymphedema	16.7% 3/18 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thromboembolic event	5.6% 1/18 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Vascular disorders - Other, specify	0.00% 0/18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.2% 1/45 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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