Trial Outcomes & Findings for Ipatasertib in Combination With Carboplatin, Carboplatin/Paclitaxel, or Capecitabine/Atezolizumab in Treating Patients With Metastatic Triple Negative Breast Cancer (NCT NCT03853707)

NCT ID: NCT03853707

Last Updated: 2024-02-20

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 28 participants
• Primary outcome timeframe: Up to 36 months
• Results posted on: 2024-02-20

Participant Flow

Participant milestones

Measure	Arm A (Ipatasertib, Carboplatin, Paclitaxel) Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes and 80 mg/m2 paclitaxel IV over 60 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Ipatasertib and Carboplatin) Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm C (Ipatasertib, Capecitabine, Atezolizumab) Patients receive 300 mg ipatasertib PO QD on days 1-21, 750 mg/m2 capecitabine PO BID on days 1-7 and 15-21, and 840 mg atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	10	12	6
Overall Study COMPLETED	10	12	6
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ipatasertib in Combination With Carboplatin, Carboplatin/Paclitaxel, or Capecitabine/Atezolizumab in Treating Patients With Metastatic Triple Negative Breast Cancer

Baseline characteristics by cohort

Measure	Arm A (Ipatasertib, Carboplatin, Paclitaxel) n=10 Participants Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes and 80 mg/m2 paclitaxel IV over 60 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Ipatasertib and Carboplatin) n=12 Participants Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm C (Ipatasertib, Capecitabine, Atezolizumab) n=6 Participants Patients receive 300 mg ipatasertib PO QD on days 1-21, 750 mg/m2 capecitabine PO BID on days 1-7 and 15-21, and 840 mg atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Total n=28 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	54 years n=7 Participants	53 years n=5 Participants	53 years n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	6 Participants n=5 Participants	28 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized African American	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Non-Hispanic White	6 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	12 participants n=7 Participants	6 participants n=5 Participants	28 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 36 months

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

Outcome measures

Measure	Arm A (Ipatasertib, Carboplatin, Paclitaxel) n=10 Participants Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes and 80 mg/m2 paclitaxel IV over 60 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Ipatasertib and Carboplatin) n=12 Participants Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm C (Ipatasertib, Capecitabine, Atezolizumab) n=6 Participants Patients receive 300 mg ipatasertib PO QD on days 1-21, 750 mg/m2 capecitabine PO BID on days 1-7 and 15-21, and 840 mg atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Progression-free Survival (PFS)	4.8 Months Interval 2.8 to NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	3.9 Months Interval 2.8 to NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	8.2 Months Interval 4.6 to NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

SECONDARY outcome

Timeframe: Up to 36 months

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	Arm A (Ipatasertib, Carboplatin, Paclitaxel) n=10 Participants Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes and 80 mg/m2 paclitaxel IV over 60 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Ipatasertib and Carboplatin) n=12 Participants Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm C (Ipatasertib, Capecitabine, Atezolizumab) n=6 Participants Patients receive 300 mg ipatasertib PO QD on days 1-21, 750 mg/m2 capecitabine PO BID on days 1-7 and 15-21, and 840 mg atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Response	7 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 6 months

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): At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR; Stable disease (SD): Neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD; Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). Clinical Benefit Rate (CBR) = CR + PR + SD at 6 months.

Outcome measures

Measure	Arm A (Ipatasertib, Carboplatin, Paclitaxel) n=10 Participants Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes and 80 mg/m2 paclitaxel IV over 60 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Ipatasertib and Carboplatin) n=12 Participants Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm C (Ipatasertib, Capecitabine, Atezolizumab) n=6 Participants Patients receive 300 mg ipatasertib PO QD on days 1-21, 750 mg/m2 capecitabine PO BID on days 1-7 and 15-21, and 840 mg atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Clinical Benefit Rate	20.0 percentage of participants	41.7 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 36 months

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

Outcome measures

Measure	Arm A (Ipatasertib, Carboplatin, Paclitaxel) n=10 Participants Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes and 80 mg/m2 paclitaxel IV over 60 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Ipatasertib and Carboplatin) n=12 Participants Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm C (Ipatasertib, Capecitabine, Atezolizumab) n=6 Participants Patients receive 300 mg ipatasertib PO QD on days 1-21, 750 mg/m2 capecitabine PO BID on days 1-7 and 15-21, and 840 mg atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Survival (OS)	11.2 Months Interval 7.2 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.	17.0 Months Interval 9.5 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.	NA Months Interval 11.1 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.

Adverse Events

Arm A (Ipatasertib, Carboplatin, Paclitaxel)

Serious events: 2 serious events

Other events: 10 other events

Deaths: 6 deaths

Arm B (Ipatasertib and Carboplatin)

Serious events: 4 serious events

Other events: 12 other events

Deaths: 10 deaths

Arm C (Ipatasertib, Capecitabine, Atezolizumab)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Measure	Arm A (Ipatasertib, Carboplatin, Paclitaxel) n=10 participants at risk Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes and 80 mg/m2 paclitaxel IV over 60 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Ipatasertib and Carboplatin) n=12 participants at risk Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm C (Ipatasertib, Capecitabine, Atezolizumab) n=6 participants at risk Patients receive 300 mg ipatasertib PO QD on days 1-21, 750 mg/m2 capecitabine PO BID on days 1-7 and 15-21, and 840 mg atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
General disorders Fever	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Measure	Arm A (Ipatasertib, Carboplatin, Paclitaxel) n=10 participants at risk Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes and 80 mg/m2 paclitaxel IV over 60 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Ipatasertib and Carboplatin) n=12 participants at risk Patients receive 300 mg ipatasertib PO QD on days 1-28. Patients also receive AUC 2 carboplatin IV over 30 minutes on days 1, 8, and 15 or days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm C (Ipatasertib, Capecitabine, Atezolizumab) n=6 participants at risk Patients receive 300 mg ipatasertib PO QD on days 1-21, 750 mg/m2 capecitabine PO BID on days 1-7 and 15-21, and 840 mg atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	90.0% 9/10 • Number of events 43 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 9/12 • Number of events 39 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 15 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Chest pain - cardiac	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	40.0% 4/10 • Number of events 7 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	41.7% 5/12 • Number of events 12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "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	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Vertigo	10.0% 1/10 • Number of events 4 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Endocrine disorders Hypothyroidism	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 4 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Blurred vision	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 2/12 • Number of events 5 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Dry eye	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders VISION CHANGES	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders darkening of vision	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders ABDOMINAL BLOATING	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	30.0% 3/10 • Number of events 8 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	41.7% 5/12 • Number of events 12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 5 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	70.0% 7/10 • Number of events 12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 10/12 • Number of events 20 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	90.0% 9/10 • Number of events 51 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 12/12 • Number of events 60 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 25 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 2/12 • Number of events 10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 2/12 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders GERD	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastritis	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal pain	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Malabsorption	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mouth Sore	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	20.0% 2/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 2/12 • Number of events 9 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	80.0% 8/10 • Number of events 21 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 9/12 • Number of events 37 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 5/6 • Number of events 27 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral pain	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral sensitivity	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Stomach pain	20.0% 2/10 • Number of events 8 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Tooth broke off	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	30.0% 3/10 • Number of events 9 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 6/12 • Number of events 9 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders heartburn	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders mouth sore	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders oral sensitivity	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders scratchy throat	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders tongue sensitivity	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Death NOS	40.0% 4/10 • Number of events 4 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 10/12 • Number of events 10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema face	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	20.0% 2/10 • Number of events 12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	60.0% 6/10 • Number of events 17 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 10/12 • Number of events 41 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 6/6 • Number of events 49 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Flu like symptoms	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Malaise	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 12 • Adverse events occurred over a period of 3 years and 1 month. "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	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 3/12 • Number of events 15 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	20.0% 2/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 6/12 • Number of events 12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 5 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders RIGHT BIG TOENAIL	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders RIGHT BIG TOENAIL DISFGURED	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders RIGHT BIG TOENAIL DISFIGURED	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 11 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders RIGHT BIG TOENIAL DISFIGURED	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders night sweats	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations COVID-19	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Folliculitis	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Right finger with pus	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Thrush	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Tooth infection	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Urinary tract infection	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	20.0% 2/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations AMAYLASE INCREASE	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	40.0% 4/10 • Number of events 7 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 3/12 • Number of events 8 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 14 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	40.0% 4/10 • Number of events 13 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	41.7% 5/12 • Number of events 11 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 11 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	30.0% 3/10 • Number of events 6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 3/12 • Number of events 8 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 15 • Adverse events occurred over a period of 3 years and 1 month. "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% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Cholesterol high	60.0% 6/10 • Number of events 10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	41.7% 5/12 • Number of events 13 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 15 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 2/12 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	40.0% 4/10 • Number of events 12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 6/12 • Number of events 20 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	100.0% 10/10 • Number of events 49 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	58.3% 7/12 • Number of events 47 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 8 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	10.0% 1/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 8/12 • Number of events 35 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "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% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations White blood cell decreased	90.0% 9/10 • Number of events 43 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 10/12 • Number of events 60 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 23 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	40.0% 4/10 • Number of events 11 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	20.0% 2/10 • Number of events 7 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	40.0% 4/10 • Number of events 9 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 9/12 • Number of events 42 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperkalemia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperphosphatemia	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypertriglyceridemia	30.0% 3/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 3/12 • Number of events 20 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 16 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	40.0% 4/10 • Number of events 11 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 3/12 • Number of events 6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	40.0% 4/10 • Number of events 17 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 2/12 • Number of events 4 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoglycemia	10.0% 1/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 3/12 • Number of events 11 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 8 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	50.0% 5/10 • Number of events 11 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	41.7% 5/12 • Number of events 17 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypomagnesemia	40.0% 4/10 • Number of events 25 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	58.3% 7/12 • Number of events 29 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	40.0% 4/10 • Number of events 11 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 9/12 • Number of events 23 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 18 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	20.0% 2/10 • Number of events 7 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 4/12 • Number of events 7 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "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	10.0% 1/10 • Number of events 8 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "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% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "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	20.0% 2/10 • Number of events 7 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	58.3% 7/12 • Number of events 28 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 8 • Adverse events occurred over a period of 3 years and 1 month. "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	30.0% 3/10 • Number of events 4 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	10.0% 1/10 • Number of events 4 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 6 • Adverse events occurred over a period of 3 years and 1 month. "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 cramp	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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 upper limb	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	20.0% 2/10 • Number of events 4 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	20.0% 2/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 7 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Cognitive disturbance	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dysgeusia	20.0% 2/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Extrapyramidal disorder	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	20.0% 2/10 • Number of events 4 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	41.7% 5/12 • Number of events 21 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Neuralgia	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Paresthesia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	60.0% 6/10 • Number of events 28 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 6/12 • Number of events 30 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 18 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Presyncope	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Restless leg syndrome	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders brain fog	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Restlessness	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Dysuria	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 2/12 • Number of events 5 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "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	30.0% 3/10 • Number of events 4 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 3/12 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal mucositis	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.0% 1/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Postnasal drip	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	20.0% 2/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 2/12 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	20.0% 2/10 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Bleeding of old radiation burn	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 4 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	40.0% 4/10 • Number of events 6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 4/12 • Number of events 11 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 7 • Adverse events occurred over a period of 3 years and 1 month. "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	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	40.0% 4/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 4/12 • Number of events 9 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "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 PEELING (FINGERTIPS)	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Scalp pain	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/12 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Flushing	20.0% 2/10 • Number of events 2 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 4/12 • Number of events 7 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hot flashes	10.0% 1/10 • Number of events 1 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 11 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	90.0% 9/10 • Number of events 46 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 10/12 • Number of events 47 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 29 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	30.0% 3/10 • Number of events 5 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 3/12 • Number of events 8 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Lymphedema	0.00% 0/10 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 1/12 • Number of events 3 • Adverse events occurred over a period of 3 years and 1 month. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events occurred over a period of 3 years and 1 month. "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