Trial Outcomes & Findings for Veliparib With or Without Carboplatin in Treating Patients With Stage III or IV Breast Cancer (NCT NCT01149083)

Last Updated: 2025-08-15

Results Overview

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. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

77 participants

Primary outcome timeframe

Up to 8 weeks post-treatment

Results posted on

2025-08-15

Participant Flow

28 patients were enrolled in the Phase I trial and 49 patients in the Phase II trial. However, 5 were either inevaluable or did not start treatment, resulting in 44 patients included in the final sample. Of those 5 patients, 3 did not get any drug due to consent withdrawal or choosing other therapy. The remaining 2 were treated but were deemed inevaluable due to not receiving enough drug per protocol. Hence there is data sent to the NCI on those 2 patients who were not part of the analysis.

Participant milestones

Participant milestones
Measure	Arm A, Dose Level 1 - 50 mg Veliparib, AUC 6 Carboplatin (Phase I) Patients receive veliparib 50 mg PO BID on days 1-21 of each cycle and carboplatin AUC 6 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level -1 - 50 mg Veliparib, AUC 5 Carboplatin (Phase I) Patients receive veliparib 50 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level A - 100 mg Veliparib, AUC 5 Carboplatin (Phase I) Patients receive veliparib 100 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level B - 150 mg Veliparib, AUC 5 Carboplatin (Phase I) Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level C - 200 mg Veliparib, AUC 5 Carboplatin (Phase I) Patients receive veliparib 200 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA I Carriers (Phase II) Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA II Carriers (Phase II) Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.
Overall Study STARTED	7	6	3	6	6	24	22
Overall Study COMPLETED	7	6	3	6	6	22	22
Overall Study NOT COMPLETED	0	0	0	0	0	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Veliparib With or Without Carboplatin in Treating Patients With Stage III or IV Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A, Dose Level 1 - 50 mg Veliparib, AUC 6 Carboplatin (Phase I) n=7 Participants Patients receive veliparib 50 mg PO BID on days 1-21 of each cycle and carboplatin AUC 6 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level -1 - 50 mg Veliparib, AUC 5 Carboplatin (Phase I) n=6 Participants Patients receive veliparib 50 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level A - 100 mg Veliparib, AUC 5 Carboplatin (Phase I) n=3 Participants Patients receive veliparib 100 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level B - 150 mg Veliparib, AUC 5 Carboplatin (Phase I) n=6 Participants Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level C - 200 mg Veliparib, AUC 5 Carboplatin (Phase I) n=6 Participants Patients receive veliparib 200 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA I Carriers (Phase II) n=22 Participants Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA II Carriers (Phase II) n=22 Participants Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Total n=72 Participants Total of all reporting groups
Age, Continuous	47 Years n=5 Participants	53 Years n=7 Participants	44 Years n=5 Participants	52 Years n=4 Participants	44 Years n=21 Participants	42 Years n=10 Participants	44 Years n=115 Participants	43 Years n=24 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	22 Participants n=10 Participants	22 Participants n=115 Participants	72 Participants n=24 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=24 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	7 Participants n=10 Participants	1 Participants n=115 Participants	8 Participants n=24 Participants
Race/Ethnicity, Customized Caucasian	6 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	11 Participants n=10 Participants	5 Participants n=115 Participants	41 Participants n=24 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=10 Participants	15 Participants n=115 Participants	22 Participants n=24 Participants
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	3 participants n=5 Participants	6 participants n=4 Participants	6 participants n=21 Participants	22 participants n=10 Participants	22 participants n=115 Participants	72 participants n=24 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks post-treatment

Population: Arm A includes all patients across dose levels (DL1-DL5) in the safety lead-in Phase I portion of the study, while Arm B comprises only BRCA1 and BRCA2 mutation carriers in the Phase II portion. The protocol pre-specified that the response rate for Phase I would be collected and reported as a single arm/group.

Outcome measures

Outcome measures
Measure	Arm A - Safety Lead-in (Phase I) n=27 Participants Patients receive a starting dose of 50 mg veliparib PO BID on days 1-21 of each cycle and 5 AUC carboplatin IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA I Carriers (Phase II) n=22 Participants Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA II Carriers (Phase II) n=22 Participants Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level B - 150 mg Veliparib, AUC 5 Carboplatin (Phase I) Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level C - 200 mg Veliparib, AUC 5 Carboplatin (Phase I) Patients receive veliparib 200 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.
Number of Subject With Overall Response	15 Participants	3 Participants	8 Participants	—	—

PRIMARY outcome

Timeframe: From start of treatment to time of progression or death from any cause, whichever occurs first, assessed up to at least 1 year

Population: Arm A includes all patients across dose levels (DL1-DL5) in the safety lead-in Phase I portion of the study, while Arm B comprises only BRCA1 and BRCA2 mutation carriers in the Phase II portion. The protocol pre-specified that progression-free survival for Phase I would be summarized and reported as a single arm/group.

Progression-free survival will be summarized as time from first protocol treatment until progression or death from any cause, using the product-limit Kaplan-Meier estimator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Outcome measures
Measure	Arm A - Safety Lead-in (Phase I) n=27 Participants Patients receive a starting dose of 50 mg veliparib PO BID on days 1-21 of each cycle and 5 AUC carboplatin IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA I Carriers (Phase II) n=22 Participants Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA II Carriers (Phase II) n=22 Participants Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level B - 150 mg Veliparib, AUC 5 Carboplatin (Phase I) Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level C - 200 mg Veliparib, AUC 5 Carboplatin (Phase I) Patients receive veliparib 200 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.
Progression-free Survival	8.7 Months Interval 7.3 to 10.6	3.6 Months Interval 2.0 to 6.4	6.6 Months Interval 5.2 to 9.6	—	—

SECONDARY outcome

Timeframe: 21 days from start of treatment, up to 2 years

The maximum tolerated dose of veliparib in combination with AUC 5 of Carboplatin is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design.

Outcome measures

Outcome measures
Measure	Arm A - Safety Lead-in (Phase I) n=28 Participants Patients receive a starting dose of 50 mg veliparib PO BID on days 1-21 of each cycle and 5 AUC carboplatin IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA I Carriers (Phase II) Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA II Carriers (Phase II) Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level B - 150 mg Veliparib, AUC 5 Carboplatin (Phase I) Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level C - 200 mg Veliparib, AUC 5 Carboplatin (Phase I) Patients receive veliparib 200 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.
Maximum Tolerated Dose (MTD)	150 mg	—	—	—	—

SECONDARY outcome

Timeframe: During the first cycle of treatment, up to 21 days

Population: This is a Phase I/II trial with the Phase I portion designed to determine the maximum tolerated dose of veliparib in combination with carboplatin. Arm A is separated into 5 different dose levels to adequately evaluate DLTs.

Dose-limiting toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Pre-specified DLT criteria included the following adverse events (AE), judged to be at least possibly related to study therapy: any grade III non-hematological toxicity not reversible to grade II or less within 96 hours, or any grade IV toxicity (excluding alopecia or controllable nausea and vomiting). Additionally, patients unable to take 80% of the planned ABT-888 due to toxicity/tolerability will be considered to have had a DLT.

Outcome measures

Outcome measures
Measure	Arm A - Safety Lead-in (Phase I) n=7 Participants Patients receive a starting dose of 50 mg veliparib PO BID on days 1-21 of each cycle and 5 AUC carboplatin IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA I Carriers (Phase II) n=6 Participants Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA II Carriers (Phase II) n=3 Participants Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level B - 150 mg Veliparib, AUC 5 Carboplatin (Phase I) n=6 Participants Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level C - 200 mg Veliparib, AUC 5 Carboplatin (Phase I) n=6 Participants Patients receive veliparib 200 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.
Number of Participants With at Least One Dose Limiting Toxicity (DLT) - Phase I	2 Participants	1 Participants	0 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: From start of treatment to time of death from any cause, assessed up to at least 3 years

Population: Arm A includes all patients across dose levels (DL1-DL5) in the safety lead-in Phase I portion of the study, while Arm B comprises only BRCA1 and BRCA2 mutation carriers in the Phase II portion. The protocol pre-specified that outcomes for Phase I would be summarized and reported as a single arm/group.

Overall survival will be summarized as time from first protocol treatment until death from any cause, using the product-limit Kaplan-Meier estimator.

Outcome measures

Outcome measures
Measure	Arm A - Safety Lead-in (Phase I) n=27 Participants Patients receive a starting dose of 50 mg veliparib PO BID on days 1-21 of each cycle and 5 AUC carboplatin IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA I Carriers (Phase II) n=22 Participants Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA II Carriers (Phase II) n=22 Participants Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level B - 150 mg Veliparib, AUC 5 Carboplatin (Phase I) Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level C - 200 mg Veliparib, AUC 5 Carboplatin (Phase I) Patients receive veliparib 200 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.
Overall Survival	18.8 Months Interval 15.0 to 23.2	11.9 Months Interval 11.2 to The upper confidence limit for overall survival is "not reached".	14.7 Months Interval 12.0 to The upper confidence limit for overall survival is "not reached".	—	—

Adverse Events

Arm A, Dose Level 1 - 50 mg Veliparib, AUC 6 Carboplatin (Phase I)

Serious events: 6 serious events

Other events: 7 other events

Deaths: 6 deaths

Arm A, Dose Level -1 - 50 mg Veliparib, AUC 5 Carboplatin (Phase I)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 6 deaths

Arm A, Dose Level A - 100 mg Veliparib, AUC 5 Carboplatin (Phase I)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Arm A, Dose Level B - 150 mg Veliparib, AUC 5 Carboplatin (Phase I)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 4 deaths

Arm A, Dose Level C - 200 mg Veliparib, AUC 5 Carboplatin (Phase I)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 4 deaths

Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA I Carriers (Phase II)

Serious events: 8 serious events

Other events: 22 other events

Deaths: 11 deaths

Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA II Carriers (Phase II)

Serious events: 6 serious events

Other events: 22 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Arm A, Dose Level 1 - 50 mg Veliparib, AUC 6 Carboplatin (Phase I) n=7 participants at risk Patients receive veliparib 50 mg PO BID on days 1-21 of each cycle and carboplatin AUC 6 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level -1 - 50 mg Veliparib, AUC 5 Carboplatin (Phase I) n=6 participants at risk Patients receive veliparib 50 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level A - 100 mg Veliparib, AUC 5 Carboplatin (Phase I) n=3 participants at risk Patients receive veliparib 100 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level B - 150 mg Veliparib, AUC 5 Carboplatin (Phase I) n=6 participants at risk Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level C - 200 mg Veliparib, AUC 5 Carboplatin (Phase I) n=6 participants at risk Patients receive veliparib 200 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA I Carriers (Phase II) n=22 participants at risk Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA II Carriers (Phase II) n=22 participants at risk Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.
Nervous system disorders Gait disturbance	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood bilirubin increased	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Cardiac arrest	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Death NOS	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Dysphasia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastroparesis	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Generalized muscle weakness	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypercalcemia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypernatremia	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypokalemia	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypophosphatemia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Lethargy	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Papulopustular rash	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Surgical and medical procedures Surgical and medical procedures - Other, specify	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thromboembolic event	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophagitis	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Hepatobiliary disorders Hepatic failure	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	28.6% 2/7 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	28.6% 2/7 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Seizure	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Agitation	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Breast pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Other adverse events
Measure	Arm A, Dose Level 1 - 50 mg Veliparib, AUC 6 Carboplatin (Phase I) n=7 participants at risk Patients receive veliparib 50 mg PO BID on days 1-21 of each cycle and carboplatin AUC 6 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level -1 - 50 mg Veliparib, AUC 5 Carboplatin (Phase I) n=6 participants at risk Patients receive veliparib 50 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level A - 100 mg Veliparib, AUC 5 Carboplatin (Phase I) n=3 participants at risk Patients receive veliparib 100 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level B - 150 mg Veliparib, AUC 5 Carboplatin (Phase I) n=6 participants at risk Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm A, Dose Level C - 200 mg Veliparib, AUC 5 Carboplatin (Phase I) n=6 participants at risk Patients receive veliparib 200 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA I Carriers (Phase II) n=22 participants at risk Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.	Arm B - 150 mg Veliparib, AUC 5 Carboplatin BRCA II Carriers (Phase II) n=22 participants at risk Patients receive veliparib 150 mg PO BID on days 1-21 of each cycle and carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle. Cycles repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and may optionally undergo biopsies throughout the study. Patients undergo blood sample collection during screening and on study.
Infections and infestations Bronchial infection	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Chest pain - cardiac	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Cholesterol high	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 27 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood bilirubin increased	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood lactate dehydrogenase increased	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Blurred vision	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Acute kidney injury	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Allergic reaction	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Anemia	100.0% 7/7 • Number of events 85 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 93 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 28 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 137 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 52 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	63.6% 14/22 • Number of events 71 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	81.8% 18/22 • Number of events 111 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Arthralgia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Bacteremia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Bloating	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Chronic kidney disease	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Conjunctivitis	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Dry eye	14.3% 1/7 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dysarthria	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Dysgeusia	28.6% 2/7 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Dysmenorrhea	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema cerebral	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema face	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Ejection fraction decreased	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Electrocardiogram QT corrected interval prolonged	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Epistaxis	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Eye disorders - Other, specify	28.6% 2/7 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fall	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Flank pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Flu like symptoms	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations GGT increased	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders General disorders and administration site conditions - Other, specify	14.3% 1/7 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Generalized muscle weakness	42.9% 3/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Gum infection	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Hearing impaired	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hematuria	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hemoglobin increased	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Hoarseness	28.6% 2/7 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypercalcemia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperglycemia	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 19 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.8% 7/22 • Number of events 44 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.4% 8/22 • Number of events 63 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Hyperhidrosis	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 30 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 32 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperkalemia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypermagnesemia	14.3% 1/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypernatremia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperphosphatemia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypertriglyceridemia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 28 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperuricemia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypoalbuminemia	28.6% 2/7 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypocalcemia	28.6% 2/7 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 5/6 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.3% 6/22 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypoglycemia	42.9% 3/7 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypokalemia	42.9% 3/7 • Number of events 19 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.2% 4/22 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypomagnesemia	14.3% 1/7 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 26 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyponatremia	42.9% 3/7 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 5/6 • Number of events 35 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.2% 4/22 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.3% 6/22 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypophosphatemia	14.3% 1/7 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders Immune system disorders - Other, specify	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Otitis externa	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Infusion related reaction	14.3% 1/7 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Joint range of motion decreased	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Lethargy	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count increased	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Malaise	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Movements involuntary	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Nail discoloration	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Nail loss	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	42.9% 3/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral dysesthesia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Paresthesia	71.4% 5/7 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 37 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.2% 4/22 • Number of events 31 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Periorbital edema	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Postnasal drip	28.6% 2/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Presyncope	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Proteinuria	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Purpura	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	28.6% 2/7 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	28.6% 2/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Restlessness	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders Shingles	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	42.9% 3/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.2% 4/22 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Somnolence	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Sore throat	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Spasticity	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thrombotic thrombocytopenic purpura	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary tract pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Vertigo	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations White blood cell decreased	71.4% 5/7 • Number of events 79 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 5/6 • Number of events 99 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 5/6 • Number of events 104 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 5/6 • Number of events 49 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	45.5% 10/22 • Number of events 62 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	68.2% 15/22 • Number of events 118 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Palpitations	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Pericardial effusion	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Pericarditis	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	42.9% 3/7 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Supraventricular tachycardia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Ear pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Tinnitus	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	57.1% 4/7 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.3% 6/22 • Number of events 32 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.9% 9/22 • Number of events 21 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	85.7% 6/7 • Number of events 23 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 5/6 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.4% 8/22 • Number of events 40 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	63.6% 14/22 • Number of events 59 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	57.1% 4/7 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.4% 8/22 • Number of events 15 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	45.5% 10/22 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	28.6% 2/7 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Flatulence	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastritis	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Hemorrhoids	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	42.9% 3/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.2% 4/22 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	100.0% 7/7 • Number of events 31 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 6/6 • Number of events 25 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 5/6 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 5/6 • Number of events 22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	81.8% 18/22 • Number of events 91 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 22/22 • Number of events 154 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Pharyngitis	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral pain	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Stomach pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Toothache	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	71.4% 5/7 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	45.5% 10/22 • Number of events 22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	77.3% 17/22 • Number of events 62 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.2% 4/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Facial pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	100.0% 7/7 • Number of events 59 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 59 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 5/6 • Number of events 35 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 23 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	63.6% 14/22 • Number of events 98 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	81.8% 18/22 • Number of events 146 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Injection site reaction	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Irritability	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Localized edema	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	71.4% 5/7 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.2% 4/22 • Number of events 33 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.4% 8/22 • Number of events 88 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Laryngitis	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Lip infection	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Nail infection	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Rhinitis infective	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sinusitis	14.3% 1/7 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper respiratory infection	14.3% 1/7 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Urinary tract infection	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Vaginal infection	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Wound infection	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Bruising	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Fracture	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Intraoperative head and neck injury	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	42.9% 3/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.4% 8/22 • Number of events 28 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.4% 8/22 • Number of events 32 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	42.9% 3/7 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 5/6 • Number of events 30 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 56 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	45.5% 10/22 • Number of events 55 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 11/22 • Number of events 41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	57.1% 4/7 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 24 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 15 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	45.5% 10/22 • Number of events 30 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 11/22 • Number of events 32 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations INR increased	14.3% 1/7 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	85.7% 6/7 • Number of events 73 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 5/6 • Number of events 90 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 39 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.9% 9/22 • Number of events 54 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.8% 7/22 • Number of events 51 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	71.4% 5/7 • Number of events 41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 52 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 5/6 • Number of events 70 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	45.5% 10/22 • Number of events 44 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	45.5% 10/22 • Number of events 41 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	71.4% 5/7 • Number of events 66 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 83 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 44 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 6/6 • Number of events 85 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 48 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	63.6% 14/22 • Number of events 42 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	63.6% 14/22 • Number of events 55 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	14.3% 1/7 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 39 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 25 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 52 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Acidosis	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	71.4% 5/7 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.4% 8/22 • Number of events 25 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood bicarbonate decreased	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	42.9% 3/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Obesity	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 30 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Back pain	14.3% 1/7 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.8% 7/22 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Bone pain	42.9% 3/7 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.2% 4/22 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 15 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint range of motion decreased lumbar spine	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myalgia	28.6% 2/7 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 43 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.2% 4/22 • Number of events 15 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	28.6% 2/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Cognitive disturbance	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	28.6% 2/7 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.9% 9/22 • Number of events 20 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	59.1% 13/22 • Number of events 31 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Encephalopathy	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	57.1% 4/7 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 5/6 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.8% 7/22 • Number of events 22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.9% 9/22 • Number of events 45 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Memory impairment	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	42.9% 3/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.2% 4/22 • Number of events 32 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Seizure	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Sinus pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Syncope	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Tremor	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Agitation	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	42.9% 3/7 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.2% 4/22 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.8% 7/22 • Number of events 36 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Confusion	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	14.3% 1/7 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 16 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.2% 4/22 • Number of events 30 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	28.6% 2/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 24 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.8% 7/22 • Number of events 24 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 15 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Libido decreased	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary frequency	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary incontinence	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urine discoloration	14.3% 1/7 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Breast pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Pelvic pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal dryness	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 15 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 18 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 3/3 • Number of events 11 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.4% 8/22 • Number of events 31 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	45.5% 10/22 • Number of events 44 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	28.6% 2/7 • Number of events 9 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 4/6 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	66.7% 2/3 • Number of events 17 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.4% 8/22 • Number of events 37 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Tracheal mucositis	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Alopecia	28.6% 2/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 29 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.8% 7/22 • Number of events 77 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Dry skin	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 5 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 8 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 3/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash acneiform	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 2/22 • Number of events 14 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Flushing	28.6% 2/7 • Number of events 3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 4 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hot flashes	28.6% 2/7 • Number of events 10 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 3/6 • Number of events 32 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 23 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.4% 8/22 • Number of events 51 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	14.3% 1/7 • Number of events 12 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 13 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 2/6 • Number of events 70 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "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 were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.7% 5/22 • Number of events 40 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	18.2% 4/22 • Number of events 24 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	14.3% 1/7 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 1/6 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 1/3 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 2 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Lymphedema	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Phlebitis	0.00% 0/7 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/3 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/6 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/22 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 1/22 • Number of events 1 • Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-218-5265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60