Trial Outcomes & Findings for Phase 1b Multicenter Study of Carfilzomib With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma (NCT NCT00603447)

Last Updated: 2017-05-30

Results Overview

Treatment-related are those AEs with possible or probable relationship to carfilzomib, lenalidomide or dexamethasone as assessed by the Investigator. The severity of each adverse event was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, per the following: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death. Serious adverse events were defined as AEs meeting one of the following: death, life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in the offspring of an exposed participant, important medical events that may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above, or pregnancy or suspected pregnancy.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

84 participants

Primary outcome timeframe

From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months.

Results posted on

2017-05-30

Participant Flow

This was an open-label study of carfilzomib (CFZ) given in combination with lenalidomide (LEN) and low-dose dexamethasone (DEX) in patients with relapsed multiple myeloma. The study consisted of a dose-escalation portion and an expansion portion. Participants were treated until disease progression (PD) or unacceptable toxicity.

In the dose-escalation portion, participants were enrolled in sequential cohorts to determine the maximum tolerated doses (MTD) of carfilzomib and lenalidomide. In the expansion portion either the MTD or the maximum planned dose (MPD) from Cohort 6 (if no MTD was determined) was administered to gain additional safety and efficacy information.

Participant milestones

Participant milestones
Measure	1: CFZ 15 mg/m² + LEN 10 mg Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	2: CFZ 15 mg/m² + LEN 15 mg Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	3: CFZ 15 mg/m² + LEN 20 mg Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	4: CFZ 20 mg/m² + LEN 20 mg Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	5: CFZ 20 mg/m² + LEN 25 mg Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	6: CFZ 20/27 mg/m² + LEN 25 mg Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	7: CFZ 20/27 mg/m² + LEN 25 mg In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
Overall Study STARTED	6	6	8	6	6	8	44
Overall Study COMPLETED	6	3	6	4	1	6	20
Overall Study NOT COMPLETED	0	3	2	2	5	2	24

Reasons for withdrawal

Reasons for withdrawal
Measure	2: CFZ 15 mg/m² + LEN 15 mg Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	3: CFZ 15 mg/m² + LEN 20 mg Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	4: CFZ 20 mg/m² + LEN 20 mg Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	5: CFZ 20 mg/m² + LEN 25 mg Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	6: CFZ 20/27 mg/m² + LEN 25 mg Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	7: CFZ 20/27 mg/m² + LEN 25 mg In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
Overall Study Adverse Event	1	1	2	1	2	10
Overall Study Other	0	1	0	3	0	13
Overall Study Withdrew Consent	2	0	0	1	0	1

Baseline Characteristics

Phase 1b Multicenter Study of Carfilzomib With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1: CFZ 15 mg/m² + LEN 10 mg n=6 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	2: CFZ 15 mg/m² + LEN 15 mg n=6 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	3: CFZ 15 mg/m² + LEN 20 mg n=8 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	4: CFZ 20 mg/m² + LEN 20 mg n=6 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	5: CFZ 20 mg/m² + LEN 25 mg n=6 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	6: CFZ 20/27 mg/m² + LEN 25 mg n=8 Participants Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	7: CFZ 20/27 mg/m² + LEN 25 mg n=44 Participants In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	Total n=84 Participants Total of all reporting groups
Age, Continuous	64.7 years STANDARD_DEVIATION 6.65 • n=5 Participants	64.2 years STANDARD_DEVIATION 12.11 • n=7 Participants	55.4 years STANDARD_DEVIATION 7.74 • n=5 Participants	61.7 years STANDARD_DEVIATION 6.68 • n=4 Participants	57.7 years STANDARD_DEVIATION 9.31 • n=21 Participants	65.4 years STANDARD_DEVIATION 7.85 • n=8 Participants	62.4 years STANDARD_DEVIATION 10.75 • n=8 Participants	61.9 years STANDARD_DEVIATION 9.86 • n=24 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	18 Participants n=8 Participants	36 Participants n=24 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	26 Participants n=8 Participants	48 Participants n=24 Participants
Race/Ethnicity, Customized African American	0 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	1 participants n=21 Participants	0 participants n=8 Participants	3 participants n=8 Participants	9 participants n=24 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	2 participants n=8 Participants	3 participants n=24 Participants
Race/Ethnicity, Customized Caucasian	6 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants	2 participants n=4 Participants	5 participants n=21 Participants	7 participants n=8 Participants	34 participants n=8 Participants	64 participants n=24 Participants
Race/Ethnicity, Customized Hispanic	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	0 participants n=21 Participants	1 participants n=8 Participants	4 participants n=8 Participants	7 participants n=24 Participants
Race/Ethnicity, Customized Other	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=8 Participants	1 participants n=8 Participants	1 participants n=24 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 (Fully active)	2 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants	2 participants n=8 Participants	23 participants n=8 Participants	33 participants n=24 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 (Restrictive but ambulatory)	4 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	5 participants n=4 Participants	4 participants n=21 Participants	6 participants n=8 Participants	17 participants n=8 Participants	46 participants n=24 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 2 (Ambulatory but unable to work)	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	4 participants n=8 Participants	5 participants n=24 Participants
Time Since Diagnosis	3.3 years n=5 Participants	2.4 years n=7 Participants	3.9 years n=5 Participants	2.8 years n=4 Participants	3.5 years n=21 Participants	4.3 years n=8 Participants	2.8 years n=8 Participants	3.1 years n=24 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months.

Population: Safety population consisting of all treated participants

Outcome measures

Outcome measures
Measure	1: CFZ 15 mg/m² + LEN 10 mg n=6 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	2: CFZ 15 mg/m² + LEN 15 mg n=6 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	3: CFZ 15 mg/m² + LEN 20 mg n=8 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	4: CFZ 20 mg/m² + LEN 20 mg n=6 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	5: CFZ 20 mg/m² + LEN 25 mg n=6 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	6: CFZ 20/27 mg/m² + LEN 25 mg n=8 Participants Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	7: CFZ 20/27 mg/m² + LEN 25 mg n=44 Participants In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
Number of Participants With Adverse Events (AEs) Any adverse event	6 participants	6 participants	8 participants	6 participants	6 participants	8 participants	44 participants
Number of Participants With Adverse Events (AEs) Treatment-related adverse event	4 participants	5 participants	8 participants	4 participants	6 participants	8 participants	43 participants
Number of Participants With Adverse Events (AEs) Grade 3 or higher adverse event	5 participants	6 participants	8 participants	6 participants	6 participants	8 participants	41 participants
Number of Participants With Adverse Events (AEs) Treatment-related Grade 3 or higher adverse event	1 participants	4 participants	7 participants	4 participants	6 participants	8 participants	38 participants
Number of Participants With Adverse Events (AEs) Serious adverse event	3 participants	3 participants	4 participants	4 participants	3 participants	6 participants	22 participants
Number of Participants With Adverse Events (AEs) AE leading to discontinuation of any study drug	1 participants	1 participants	3 participants	4 participants	2 participants	3 participants	18 participants
Number of Participants With Adverse Events (AEs) AE leading to discontinuation of carfilzomib	0 participants	0 participants	1 participants	2 participants	1 participants	1 participants	9 participants
Number of Participants With Adverse Events (AEs) Deaths within 30 days of last dose of study drug	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	3 participants

PRIMARY outcome

Timeframe: Cycle 1, 28 days

Population: Safety population for the dose escalation portion of the study

Dose-limiting toxicity was defined as any of the following events assessed as related to carfilzomib, lenalidomide, or dexamethasone: Nonhematologic * ≥ Grade 2 neuropathy with pain * ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, diarrhea, hyperglycemia due to dexamethasone, and rash due to lenalidomide) * ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal supportive therapy * ≥ Grade 4 fatigue persisting \> 7 days * Treatment delay for toxicity \> 21 days Hematologic * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/mm³) \> 7 days * Febrile neutropenia (ANC \< 1,000/mm³ with fever ≥ 38.3ºC) * Grade 4 thrombocytopenia (platelets \< 25,000/mm³) for \> 7 days despite holding treatment, or Grade 3 or 4 thrombocytopenia associated with bleeding * Treatment delay for toxicity \> 21 days. The maximum-tolerated dose was defined as the dose level below which a drug-related DLT was observed in ≥ 33% of participants in a cohort.

Outcome measures

Outcome measures
Measure	1: CFZ 15 mg/m² + LEN 10 mg n=6 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	2: CFZ 15 mg/m² + LEN 15 mg n=6 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	3: CFZ 15 mg/m² + LEN 20 mg n=8 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	4: CFZ 20 mg/m² + LEN 20 mg n=6 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	5: CFZ 20 mg/m² + LEN 25 mg n=6 Participants Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	6: CFZ 20/27 mg/m² + LEN 25 mg n=8 Participants Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	7: CFZ 20/27 mg/m² + LEN 25 mg In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
Number of Participants With Dose-limiting Toxicities	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	—

Adverse Events

1: CFZ 15 mg/m² + LEN 10 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

2: CFZ 15 mg/m² + LEN 15 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

3: CFZ 15 mg/m² + LEN 20 mg

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

4: CFZ 20 mg/m² + LEN 20 mg

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

5: CFZ 20 mg/m² + LEN 25 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

6: CFZ 20/27 mg/m² + LEN 25 mg

Serious events: 6 serious events

Other events: 8 other events

Deaths: 0 deaths

7: CFZ 20/27 mg/m² + LEN 25 mg

Serious events: 22 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1: CFZ 15 mg/m² + LEN 10 mg n=6 participants at risk Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	2: CFZ 15 mg/m² + LEN 15 mg n=6 participants at risk Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	3: CFZ 15 mg/m² + LEN 20 mg n=8 participants at risk Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	4: CFZ 20 mg/m² + LEN 20 mg n=6 participants at risk Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	5: CFZ 20 mg/m² + LEN 25 mg n=6 participants at risk Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	6: CFZ 20/27 mg/m² + LEN 25 mg n=8 participants at risk Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	7: CFZ 20/27 mg/m² + LEN 25 mg n=44 participants at risk In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Acute myocardial infarction	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial fibrillation	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Bradycardia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery disease	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Myocardial infarction	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Sick sinus syndrome	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Colonic stenosis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Death	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Disease progression	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Face oedema	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pyrexia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess jaw	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis viral	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cellulitis	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Infection	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Influenza	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Osteomyelitis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia pneumococcal	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sepsis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Viral infection	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pathological fracture	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage IV	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebrovascular accident	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Haematuria	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal failure acute	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Laryngeal mass	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Embolism	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Thrombosis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Other adverse events
Measure	1: CFZ 15 mg/m² + LEN 10 mg n=6 participants at risk Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	2: CFZ 15 mg/m² + LEN 15 mg n=6 participants at risk Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	3: CFZ 15 mg/m² + LEN 20 mg n=8 participants at risk Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	4: CFZ 20 mg/m² + LEN 20 mg n=6 participants at risk Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	5: CFZ 20 mg/m² + LEN 25 mg n=6 participants at risk Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	6: CFZ 20/27 mg/m² + LEN 25 mg n=8 participants at risk Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.	7: CFZ 20/27 mg/m² + LEN 25 mg n=44 participants at risk In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
Gastrointestinal disorders Flatulence	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gingival bleeding	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Haematochezia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	36.4% 16/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oesophageal discomfort	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oral pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oral soft tissue disorder	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Palatal disorder	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gingival swelling	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gingivitis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Stomach discomfort	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Stomatitis	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Toothache	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Vomiting	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 11/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Asthenia	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 5/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Axillary pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Catheter site haematoma	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Catheter site haemorrhage	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Catheter site pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Cyst	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest discomfort	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chills	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 5/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Disease progression	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Lacrimation increased	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Ocular hyperaemia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Vision blurred	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	13.6% 6/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal distension	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Constipation	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 11/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	66.7% 4/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 4/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	59.1% 26/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Faecal incontinence	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Anaemia	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	75.0% 6/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	31.8% 14/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Leukopenia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	20.5% 9/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Lymphopenia	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	62.5% 5/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 22/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Neutropenia	66.7% 4/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	66.7% 4/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 4/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	83.3% 5/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	36.4% 16/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	29.5% 13/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial fibrillation	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Bradycardia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Extrasystoles	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Palpitations	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Tachycardia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ventricular hypertrophy	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Cataract	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Conjunctivitis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Corneal lesion	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Dry eye	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Eye haemorrhage	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Eye irritation	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Eye pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Eye swelling	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Face oedema	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Fatigue	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	66.7% 4/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	62.5% 5/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	66.7% 4/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	75.0% 6/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	68.2% 30/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Feeling hot and cold	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Feeling jittery	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Feeling of body temperature change	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Gait disturbance	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Influenza like illness	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Infusion site bruising	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Infusion site reaction	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Injection site haemorrhage	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Injection site irritation	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Irritability	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Malaise	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Non-cardiac chest pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Oedema	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Oedema peripheral	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	66.7% 4/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	38.6% 17/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pain	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pitting oedema	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pyrexia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	62.5% 5/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 4/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	43.2% 19/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Temperature intolerance	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Vessel puncture site haemorrhage	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Drug hypersensitivity	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Seasonal allergy	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Candidiasis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Catheter site cellulitis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cellulitis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Eye infection	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Folliculitis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Fungal infection	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis viral	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Herpes simplex	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Influenza	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Lobar pneumonia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Nasopharyngitis	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	18.2% 8/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Oral candidiasis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Rhinitis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sinusitis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 4/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 4/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 4/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	43.2% 19/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Viral infection	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 5/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Incision site complication	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Scratch	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Alanine aminotransferase increased	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	15.9% 7/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Aspartate aminotransferase increased	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	13.6% 6/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood alkaline phosphatase increased	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood bicarbonate decreased	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood bilirubin increased	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood calcium decreased	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood creatinine increased	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood magnesium decreased	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Cardiac murmur	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Ejection fraction decreased	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Haemoglobin decreased	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Heart rate irregular	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations International normalised ratio increased	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Platelet count decreased	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Weight decreased	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Weight increased	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Anorexia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	15.9% 7/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Decreased appetite	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 5/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperglycaemia	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 11/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperphosphataemia	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperphosphatasaemia	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperuricaemia	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypoalbuminaemia	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 5/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	27.3% 12/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	20.5% 9/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 5/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 4/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	36.4% 16/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Lactose intolerance	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	27.3% 12/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	34.1% 15/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	13.6% 6/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscle spasms	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	66.7% 4/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 4/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	38.6% 17/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscular weakness	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 5/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 4/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 11/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 5/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Sacral pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Shoulder pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of skin	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Aphasia	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Areflexia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Balance disorder	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Convulsion	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	13.6% 6/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dysgeusia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 5/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dysstasia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 11/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hyperaesthesia	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hypoaesthesia	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	18.2% 8/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hyporeflexia	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Memory impairment	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Nerve compression	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Neuropathic pain	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 5/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Neuropathy peripheral	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	27.3% 12/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Paraesthesia	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	20.5% 9/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Sciatica	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Somnolence	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Tremor	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Affect lability	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Agitation	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Anxiety	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	15.9% 7/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Anxiety disorder	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Confusional state	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Depression	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Insomnia	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	38.6% 17/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Mood altered	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Mood swings	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Stress	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Dysuria	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Haematuria	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Incontinence	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Micturition urgency	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Nocturia	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Proteinuria	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal failure	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urinary hesitation	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urinary retention	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Atrophic vulvovaginitis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Pelvic pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	83.3% 5/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 4/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	38.6% 17/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dysphonia	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	13.6% 6/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 3/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	34.1% 15/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 5/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	13.6% 6/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Hiccups	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	15.9% 7/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	27.3% 12/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	15.9% 7/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	13.6% 6/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	37.5% 3/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dry skin	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 11/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Hair growth abnormal	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Increased tendency to bruise	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 5/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	50.0% 4/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	25.0% 2/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	18.2% 8/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.8% 3/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin exfoliation	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin fragility	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Subcutaneous nodule	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Tooth extraction	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Deep vein thrombosis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 5/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Flushing	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Haematoma	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	33.3% 2/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.1% 4/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral coldness	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Phlebitis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.3% 1/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Post thrombotic syndrome	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Thrombophlebitis superficial	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.5% 2/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Vascular fragility	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 1/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Vena cava thrombosis	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.7% 1/6 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/8 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/44 • From the first dose of study drug until 30 days after the last dose; 1 to 52 months, with an average of 12 months. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen, Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER