Trial Outcomes & Findings for Pomalidomide and Dexamethasone With or Without Ixazomib in Treating Patients With Relapsed Multiple Myeloma (NCT NCT02004275)

NCT ID: NCT02004275

Last Updated: 2023-12-01

Results Overview

For this protocol, dose-limiting toxicity (DLT) will be defined by the following adverse events at least possibly related to study therapy: Grade 3 or higher non-hematologic toxicity, with the following exceptions: Alopecia is not expected but would not be considered a DLT. Nausea, vomiting and diarrhea will only be considered a DLT if it cannot be adequately managed with optimal supportive care. Grade 3 or 4 hyperglycemia due to dexamethasone will only be considered a DLT if it cannot be controlled with appropriate therapy Grade 4 hematologic toxicity, with the following exceptions: Grade 4 lymphopenia is expected with this regimen and will not be construed as a DLT. Grade 4 neutropenia will only be considered a DLT if it lasts longer than 7 days despite appropriate supportive care. Grade 4 thrombocytopenia will only be considered a DLT if it lasts longer than 7 days or is associated with greater then or equal to grade 3 bleeding event

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

118 participants

Primary outcome timeframe

28 days

Results posted on

2023-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Pomalidomide, Dexamethasone) Patients receive 4mg of pomalidomide PO QD on days 1-21 and 40mg dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.	Arm II (Pomalidomide, Dexamethasone, Ixazomib) Patients receive 4mg pomalidomide, 40mg dexamethasone, and 4mg ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Phase 1 Dose Level 1 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase I Dose Level 2 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Phase 1 COMPLETED	0	0	3	3	6	6
Phase 1 NOT COMPLETED	0	0	0	2	1	5
Phase 2 Part 1 STARTED	45	47	0	0	0	0
Phase 2 Part 1 COMPLETED	39	38	0	0	0	0
Phase 2 Part 1 NOT COMPLETED	6	9	0	0	0	0
Phase 2 Part 2 STARTED	30	0	0	0	0	0
Phase 2 Part 2 COMPLETED	26	0	0	0	0	0
Phase 2 Part 2 NOT COMPLETED	4	0	0	0	0	0
Phase 1 STARTED	0	0	3	5	7	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Pomalidomide, Dexamethasone) Patients receive 4mg of pomalidomide PO QD on days 1-21 and 40mg dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.	Arm II (Pomalidomide, Dexamethasone, Ixazomib) Patients receive 4mg pomalidomide, 40mg dexamethasone, and 4mg ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Phase I Dose Level 2 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Phase 1 Ineligible	0	0	1	1	0
Phase 1 Protocol Violation	0	0	1	0	5
Phase 2 Part 1 Ineligible	6	9	0	0	0
Phase 2 Part 2 Withdrawal by Subject	4	0	0	0	0

Baseline Characteristics

Pomalidomide and Dexamethasone With or Without Ixazomib in Treating Patients With Relapsed Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase II Arm I (Pomalidomide, Dexamethasone) n=45 Participants Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.	Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib) n=47 Participants Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Phase 1 Dose Level 1 n=3 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 n=5 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 n=7 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 n=11 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.	Total n=118 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	67 years n=7 Participants	64.0 years n=5 Participants	63 years n=4 Participants	65 years n=21 Participants	69 years n=10 Participants	66 years n=115 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	25 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	52 Participants n=115 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	22 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=10 Participants	66 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	8 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	43 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	9 Participants n=10 Participants	97 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	13 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	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	1 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	13 Participants n=115 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	39 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	8 Participants n=10 Participants	97 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	6 Participants n=115 Participants

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=3 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 n=3 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 n=6 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 n=6 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Maximum Tolerated Dose (MTD) of Pomalidomide and Ixazomib, Determined According to Incidence of Dose Limiting Toxicity (DLT) Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (Phase I)	0 participants with DLT	0 participants with DLT	1 participants with DLT	1 participants with DLT	—	—

PRIMARY outcome

Timeframe: 3 years

Population: All eligible phase 2 patients were included in this analysis

progression-free survival (PFS), defined as the time from randomization to the date the International Myeloma Working Group (IMWG) criteria for disease progression is met. If a patient initiates another anti-cancer treatment prior to disease progression, they will be censored at the date of initiation of this treatment. Patients will be randomized to treatment using the Pocock-Simon algorithm balancing the distribution of the following stratification factors between the two treatment arms: 1) ISS 1-2 disease vs. ISS 3 disease (current ISS stage based off screening beta 2 microglobulin and albumin) 2) High risk cytogenetics features: yes vs. no High risk cytogenetics features include: del(1p), gain of 1q, t(4;14), t(14;16), t(14; 20), del(17p) 3) Prior treatment with a proteasome inhibitor: yes vs. no

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=39 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 n=38 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Progression Free Survival (PFS) (Phase II)	228 days Interval 149.0 to 466.0	619 days Interval 245.0 to Upper limit not reached due to lack of events	—	—	—	—

SECONDARY outcome

Timeframe: 44.5 months

Population: All enrolled phase 1 patients that were eligible and treated per protocol were evaluated for dose limiting toxicities. This excludes two dose level 2 patients, one dose level 3 patient and 5 dose level 4 patients.

These events are reported in the adverse events section of this report.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=3 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 n=3 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 n=6 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 n=6 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Incidence and Type of Dose Limiting Toxicities (DLTs) Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (Phase I)	0 participants with DLT	0 participants with DLT	1 participants with DLT	1 participants with DLT	—	—

SECONDARY outcome

Timeframe: 39 months

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=3 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 n=3 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 n=6 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 n=6 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Incidence of Dose Reductions/Delays (Phase I)	2 Participants	3 Participants	6 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: 3 years

Population: All eligible and treated Phase II patients were included in analysis. Phase I patients were excluded from response analysis.

ORR is defined as partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) according to International Myeloma Working Group (IMWG) Uniform Response Criteria

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=39 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 n=38 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Overall Response Rate (ORR)	.436 proportion of participants Interval 0.278 to 0.604	.632 proportion of participants Interval 0.46 to 0.782	—	—	—	—

SECONDARY outcome

Timeframe: 3 years

Disease response status is based on the IMWG criteria being held for two consecutive evaluations at least 4 weeks apart. Clinical benefit rate (CBR) is defined as proportion of patients with minimal response (MR) and better according to International Myeloma Working Group (IMWG) Uniform Response Criteria (Phase II)

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=39 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 n=38 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Clinical Benefit Rate (CBR)	.564 proportion of participants Interval 0.396 to 0.722	.737 proportion of participants Interval 0.569 to 0.866	—	—	—	—

SECONDARY outcome

Timeframe: 42 days

Proportion of patients that went two of more cycles of treatment without discontinuing treatment for progression or intolerability.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=39 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 n=38 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Disease Control Rate (DCR), Defined as Stable Disease (SD) and Better According to International Myeloma Working Group (IMWG) Uniform Response Criteria (Phase II)	.949 proportion of partcipants Interval 0.827 to 0.994	.921 proportion of partcipants Interval 0.786 to 0.983	—	—	—	—

SECONDARY outcome

Timeframe: Up to 3 years

Population: All eligible phase 2 responders

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=17 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 n=25 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Duration of Response (DOR), Calculated for All Patients Achieving an Objective Response, Partial Response (PR) or Better (Phase II)	12.3 Months Interval 2.8 to 37.0	23.7 Months Interval 13.4 to 43.1	—	—	—	—

SECONDARY outcome

Timeframe: 2 years

Overall survival was analyzed from the time of registration to the date of death or last known date living. Due to median OS time not being reached due to lack of deaths at the time of this report by either arm, the 2 year OS rate has been reported. This analysis censors living patients at 2 years.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=39 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 n=38 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Overall Survival (OS) (Phase II)	.795 proportion of patients alive Interval 0.662 to 0.928	.784 proportion of patients alive Interval 0.662 to 0.928	—	—	—	—

SECONDARY outcome

Timeframe: Up to 3 years post-registration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 92 months

The count of paitents that experenced an adverse event is reported in this section. A full table of these events is reported in the adverse event section of this report.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=45 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 n=76 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 n=3 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 n=4 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.	Phase 1 Dose Level 3 n=6 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 n=11 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Incidence, Type and Severity of Adverse Events, Graded According to National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE) Version 4.0 (Phase II)	22 Participants	33 Participants	2 Participants	2 Participants	4 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=26 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Response Rates (Overall Response Rate (ORR), Clinical Benefit Rate (CBR), Disease Control Rate (DCR) for All Patients on the Pomalidomide/Dexamethasone Arm at the Time of Cross-over to Pomalidomide/Dexamethasone/Ixazomib (Phase II) Overall Response Rate	.231 proportion of partcipants Interval 0.09 to 0.437	—	—	—	—	—
Response Rates (Overall Response Rate (ORR), Clinical Benefit Rate (CBR), Disease Control Rate (DCR) for All Patients on the Pomalidomide/Dexamethasone Arm at the Time of Cross-over to Pomalidomide/Dexamethasone/Ixazomib (Phase II) Clinical Benefit Rate	.269 proportion of partcipants Interval 0.116 to 0.478	—	—	—	—	—
Response Rates (Overall Response Rate (ORR), Clinical Benefit Rate (CBR), Disease Control Rate (DCR) for All Patients on the Pomalidomide/Dexamethasone Arm at the Time of Cross-over to Pomalidomide/Dexamethasone/Ixazomib (Phase II) Disease Control Rate	.962 proportion of partcipants Interval 0.804 to 0.999	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 3 years post-registration (at crossover)

Population: Arm 1 patients that chose to crossover to Arm 2 treatment (add IXA treatment).

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=26 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Progression Free Survival (PFS) for All Patients on the Pomalidomide/Dexamethasone Arm at the Time of Cross-over to Pomalidomide/Dexamethasone/Ixazomib (Phase II)	5.6 months Interval 3.0 to 12.9	—	—	—	—	—

SECONDARY outcome

Timeframe: baseline

Population: All patients that completed and returned the QoL survey

Pre-treatment patient-report of fatigue and overall quality of life (based on a 10-point Likert scale). A higher number indicates a better quality of life where 10 is the best outcome and 0 is the worst.

Outcome measures

Outcome measures
Measure	Phase 1 Dose Level 1 n=37 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 n=37 Participants A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.	Phase 1 Dose Level 3 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Baseline Level of Perceived Fatigue and QOL, Assessed Using the Registration Fatigue/Uniscale Assessment Form (Phase II) High QoL(7-10)	21 participants	27 participants	—	—	—	—
Baseline Level of Perceived Fatigue and QOL, Assessed Using the Registration Fatigue/Uniscale Assessment Form (Phase II) Medium or Low QoL (0-7)	16 participants	11 participants	—	—	—	—

Adverse Events

Phase II Arm I (Pomalidomide, Dexamethasone)

Serious events: 22 serious events

Other events: 45 other events

Deaths: 7 deaths

Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib) + Crossover Patients From Arm I

Serious events: 33 serious events

Other events: 76 other events

Deaths: 22 deaths

Phase 1 Dose Level 1

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1 Dose Level 2

Serious events: 2 serious events

Other events: 4 other events

Deaths: 4 deaths

Phase 1 Dose Level 3

Serious events: 4 serious events

Other events: 6 other events

Deaths: 4 deaths

Phase 1 Dose Level 4

Serious events: 6 serious events

Other events: 11 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Phase II Arm I (Pomalidomide, Dexamethasone) n=45 participants at risk Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.	Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib) + Crossover Patients From Arm I n=76 participants at risk Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Phase 1 Dose Level 1 n=3 participants at risk A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 n=4 participants at risk A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 n=6 participants at risk A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 n=11 participants at risk A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Investigations White blood cell decreased	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Dehydration	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Creatinine increased	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Lymphocyte count decreased	11.1% 5/45 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 2/6 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Neutrophil count decreased	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 2/6 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Platelet count decreased	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Neck pain	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Hypercalcemia	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Hypernatremia	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Back pain	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, mal, uncpec - Oth spec	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	4.4% 2/45 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Ataxia	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Headache	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Paresthesia	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Peripheral sensory neuropathy	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Seizure	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Stroke	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Syncope	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Transient ischemic attacks	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Psychiatric disorders Agitation	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Blood and lymphatic system disorders Anemia	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Blood and lymphatic system disorders Blood and lymph sys disorders - Oth Spec	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Atrial fibrillation	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Chest pain - cardiac	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Mitral valve disease	2.2% 1/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Myocardial infarction	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Ear and labyrinth disorders Tinnitus	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Eye disorders Blurred vision	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Abdominal pain	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Bloating	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Constipation	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Diarrhea	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Enterocolitis	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Gastrointestinal disorders - Oth spec	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Nausea	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Vomiting	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Death NOS	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Fatigue	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Fever	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Flu like symptoms	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Gen disord and admin site conds-Oth spec	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Localized edema	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Non-cardiac chest pain	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Hepatobiliary disorders Cholecystitis	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Immune system disorders Allergic reaction	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Bone infection	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Bronchial infection	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Infections and infestations - Oth spec	6.7% 3/45 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	6.6% 5/76 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Lung infection	6.7% 3/45 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 2/6 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Meningitis	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Sepsis	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Skin infection	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Upper respiratory infection	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Urinary tract infection	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Wound infection	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Injury, poisoning and procedural complications Bruising	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Injury, poisoning and procedural complications Fall	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Blood bilirubin increased	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Psychiatric disorders Insomnia	2.2% 1/45 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Renal and urinary disorders Acute kidney injury	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Dyspnea	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 2/6 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Epistaxis	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Hypoxia	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Pulmonary edema	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Resp, thoracic, mediastinal - Oth spec	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Skin and subcutaneous tissue disorders Skin and subcut tissue disord - Oth spec	6.7% 3/45 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Surgical and medical procedures Surgical and medical proced - Oth spec	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Vascular disorders Hypotension	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Vascular disorders Thromboembolic event	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables

Other adverse events

Other adverse events
Measure	Phase II Arm I (Pomalidomide, Dexamethasone) n=45 participants at risk Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.	Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib) + Crossover Patients From Arm I n=76 participants at risk Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Phase 1 Dose Level 1 n=3 participants at risk A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 2 n=4 participants at risk A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 3 n=6 participants at risk A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 3 was 4mg POM-DEX and 3mg IXA.	Phase 1 Dose Level 4 n=11 participants at risk A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 4 was 4mg POM-DEX and 4mg IXA.
Investigations Alkaline phosphatase increased	8.9% 4/45 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	7.9% 6/76 • Number of events 13 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Aspartate aminotransferase increased	8.9% 4/45 • Number of events 20 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	11.8% 9/76 • Number of events 32 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Blood bilirubin increased	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Creatinine increased	17.8% 8/45 • Number of events 16 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	22.4% 17/76 • Number of events 87 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	27.3% 3/11 • Number of events 16 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations INR increased	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Investigations - Other, specify	8.9% 4/45 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 22 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Lymphocyte count decreased	53.3% 24/45 • Number of events 101 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	57.9% 44/76 • Number of events 279 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	66.7% 2/3 • Number of events 33 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	75.0% 3/4 • Number of events 23 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	66.7% 4/6 • Number of events 53 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	72.7% 8/11 • Number of events 13 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Neutrophil count decreased	68.9% 31/45 • Number of events 181 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	72.4% 55/76 • Number of events 404 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 30 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	50.0% 2/4 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	100.0% 6/6 • Number of events 50 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	72.7% 8/11 • Number of events 45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Platelet count decreased	40.0% 18/45 • Number of events 46 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	63.2% 48/76 • Number of events 211 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 33 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	50.0% 2/4 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	100.0% 6/6 • Number of events 36 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	90.9% 10/11 • Number of events 97 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Weight gain	15.6% 7/45 • Number of events 9 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	17.1% 13/76 • Number of events 59 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Weight loss	4.4% 2/45 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Blood and lymphatic system disorders Anemia	68.9% 31/45 • Number of events 187 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	73.7% 56/76 • Number of events 420 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	100.0% 4/4 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	100.0% 6/6 • Number of events 53 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	90.9% 10/11 • Number of events 114 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Blood and lymphatic system disorders Blood and lymph sys disorders - Oth Spec	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Atrial fibrillation	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	6.6% 5/76 • Number of events 25 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Atrial flutter	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Cardiac disorders - Other, specify	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Chest pain - cardiac	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Heart failure	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Palpitations	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Paroxysmal atrial tachycardia	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Sick sinus syndrome	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 10 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Sinus bradycardia	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	7.9% 6/76 • Number of events 53 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Sinus tachycardia	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Cardiac disorders Ventricular arrhythmia	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Ear and labyrinth disorders Ear and labyrinth disorders - Oth spec	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Ear and labyrinth disorders Ear pain	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Ear and labyrinth disorders Hearing impaired	2.2% 1/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 16 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Ear and labyrinth disorders Tinnitus	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Ear and labyrinth disorders Vertigo	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 12 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Endocrine disorders Endocrine disorders - Other, specify	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Eye disorders Blurred vision	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	10.5% 8/76 • Number of events 37 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 25 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Eye disorders Cataract	2.2% 1/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	6.6% 5/76 • Number of events 14 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Eye disorders Dry eye	2.2% 1/45 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 8 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Eye disorders Eye disorders - Other, specify	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.2% 7/76 • Number of events 35 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Eye disorders Watering eyes	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 9 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Abdominal distension	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Abdominal pain	6.7% 3/45 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 15 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Anal hemorrhage	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Anal pain	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Bloating	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 8 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Constipation	26.7% 12/45 • Number of events 59 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	26.3% 20/76 • Number of events 129 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 14 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	45.5% 5/11 • Number of events 29 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Diarrhea	53.3% 24/45 • Number of events 85 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	57.9% 44/76 • Number of events 364 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	66.7% 2/3 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	50.0% 2/4 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 2/6 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	45.5% 5/11 • Number of events 28 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Dry mouth	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 21 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Dyspepsia	6.7% 3/45 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Dysphagia	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Flatulence	2.2% 1/45 • Number of events 12 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Gastritis	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Gastroesophageal reflux disease	2.2% 1/45 • Number of events 14 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	10.5% 8/76 • Number of events 26 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Gastrointestinal disorders - Oth spec	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	6.6% 5/76 • Number of events 8 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	27.3% 3/11 • Number of events 12 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Gingival pain	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 14 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Hemorrhoids	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Mucositis oral	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Nausea	26.7% 12/45 • Number of events 28 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	43.4% 33/76 • Number of events 173 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	66.7% 2/3 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	50.0% 3/6 • Number of events 8 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	36.4% 4/11 • Number of events 26 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Oral pain	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Rectal fistula	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Stomach pain	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Toothache	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Gastrointestinal disorders Vomiting	15.6% 7/45 • Number of events 9 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 19/76 • Number of events 32 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	36.4% 4/11 • Number of events 11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Chills	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Edema face	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Edema limbs	17.8% 8/45 • Number of events 25 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	32.9% 25/76 • Number of events 185 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	66.7% 2/3 • Number of events 9 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 2/6 • Number of events 15 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Edema trunk	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Fatigue	86.7% 39/45 • Number of events 241 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	86.8% 66/76 • Number of events 647 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	66.7% 2/3 • Number of events 35 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	75.0% 3/4 • Number of events 24 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	100.0% 6/6 • Number of events 59 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	90.9% 10/11 • Number of events 132 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Fever	6.7% 3/45 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Flu like symptoms	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Gait disturbance	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Gen disord and admin site conds-Oth spec	40.0% 18/45 • Number of events 99 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	26.3% 20/76 • Number of events 106 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	66.7% 2/3 • Number of events 17 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	50.0% 2/4 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	45.5% 5/11 • Number of events 28 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Localized edema	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Malaise	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Non-cardiac chest pain	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
General disorders Pain	6.7% 3/45 • Number of events 8 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	19.7% 15/76 • Number of events 40 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 2/6 • Number of events 11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	45.5% 5/11 • Number of events 17 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Immune system disorders Allergic reaction	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Immune system disorders Immune system disorders - Other, specify	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Bladder infection	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Breast infection	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Conjunctivitis	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Conjunctivitis infective	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Eye infection	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Gum infection	4.4% 2/45 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 10 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Infections and infestations - Oth spec	11.1% 5/45 • Number of events 8 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.4% 14/76 • Number of events 30 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	50.0% 2/4 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Laryngitis	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Lung infection	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Sinusitis	4.4% 2/45 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Skin infection	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	6.6% 5/76 • Number of events 13 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Tooth infection	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Upper respiratory infection	13.3% 6/45 • Number of events 10 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	13.2% 10/76 • Number of events 13 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	66.7% 2/3 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 2/6 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Urinary tract infection	6.7% 3/45 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	6.6% 5/76 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Infections and infestations Vaginal infection	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Injury, poisoning and procedural complications Bruising	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.2% 7/76 • Number of events 54 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 16 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Injury, poisoning and procedural complications Fall	11.1% 5/45 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Injury, poisoning and procedural complications Seroma	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations Alanine aminotransferase increased	13.3% 6/45 • Number of events 29 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	15.8% 12/76 • Number of events 37 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 18 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Investigations White blood cell decreased	33.3% 15/45 • Number of events 65 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	52.6% 40/76 • Number of events 264 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 21 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	75.0% 3/4 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	50.0% 3/6 • Number of events 37 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	36.4% 4/11 • Number of events 13 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Anorexia	6.7% 3/45 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.2% 7/76 • Number of events 16 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Dehydration	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.2% 7/76 • Number of events 8 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Hypercalcemia	6.7% 3/45 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Hyperglycemia	42.2% 19/45 • Number of events 81 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	55.3% 42/76 • Number of events 235 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	36.4% 4/11 • Number of events 85 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Hyperkalemia	2.2% 1/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Hypernatremia	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Hypoalbuminemia	8.9% 4/45 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	10.5% 8/76 • Number of events 16 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	27.3% 3/11 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Hypocalcemia	8.9% 4/45 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	17.1% 13/76 • Number of events 29 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Hypoglycemia	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Hypokalemia	15.6% 7/45 • Number of events 10 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	22.4% 17/76 • Number of events 29 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 2/6 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Hypomagnesemia	22.2% 10/45 • Number of events 41 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.4% 14/76 • Number of events 56 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Hyponatremia	8.9% 4/45 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	14.5% 11/76 • Number of events 15 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Hypophosphatemia	20.0% 9/45 • Number of events 27 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 19/76 • Number of events 52 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 2/6 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 19 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Metabolism, nutrition disord - Oth spec	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Metabolism and nutrition disorders Obesity	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Arthralgia	4.4% 2/45 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	13.2% 10/76 • Number of events 86 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	27.3% 3/11 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Arthritis	4.4% 2/45 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Back pain	31.1% 14/45 • Number of events 31 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	22.4% 17/76 • Number of events 74 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	36.4% 4/11 • Number of events 63 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Bone pain	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	10.5% 8/76 • Number of events 36 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Flank pain	2.2% 1/45 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Generalized muscle weakness	17.8% 8/45 • Number of events 11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	10.5% 8/76 • Number of events 33 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 2/6 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 15 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	4.4% 2/45 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 24 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Musculoskeletal, conn tissue - Oth spec	11.1% 5/45 • Number of events 18 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	6.6% 5/76 • Number of events 24 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Myalgia	15.6% 7/45 • Number of events 29 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.4% 14/76 • Number of events 79 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 28 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Neck pain	2.2% 1/45 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	6.7% 3/45 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 8 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Musculoskeletal and connective tissue disorders Pain in extremity	15.6% 7/45 • Number of events 12 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	10.5% 8/76 • Number of events 50 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 15 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	50.0% 2/4 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 12 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, mal, uncpec - Oth spec	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Cognitive disturbance	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Concentration impairment	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Dizziness	17.8% 8/45 • Number of events 18 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.4% 14/76 • Number of events 90 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	27.3% 3/11 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Dysgeusia	4.4% 2/45 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 17 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	66.7% 2/3 • Number of events 20 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Dysphasia	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Headache	15.6% 7/45 • Number of events 18 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	15.8% 12/76 • Number of events 42 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	66.7% 2/3 • Number of events 30 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Lethargy	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Memory impairment	4.4% 2/45 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Muscle weakness left-sided	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Nervous system disorders - Oth spec	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 2/6 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	36.4% 4/11 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Paresthesia	4.4% 2/45 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 18 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Peripheral motor neuropathy	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Peripheral sensory neuropathy	68.9% 31/45 • Number of events 298 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	75.0% 57/76 • Number of events 559 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	75.0% 3/4 • Number of events 24 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	83.3% 5/6 • Number of events 56 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	63.6% 7/11 • Number of events 24 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Presyncope	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Somnolence	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Syncope	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Tremor	13.3% 6/45 • Number of events 31 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	11.8% 9/76 • Number of events 33 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	66.7% 2/3 • Number of events 32 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 2/6 • Number of events 15 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 10 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Nervous system disorders Vasovagal reaction	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Psychiatric disorders Agitation	11.1% 5/45 • Number of events 8 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.2% 7/76 • Number of events 44 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Psychiatric disorders Anxiety	22.2% 10/45 • Number of events 30 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	13.2% 10/76 • Number of events 38 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	66.7% 2/3 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 17 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	36.4% 4/11 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Psychiatric disorders Confusion	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Psychiatric disorders Depression	8.9% 4/45 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	14.5% 11/76 • Number of events 44 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Psychiatric disorders Insomnia	40.0% 18/45 • Number of events 85 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	32.9% 25/76 • Number of events 204 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	66.7% 2/3 • Number of events 19 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	50.0% 2/4 • Number of events 29 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Psychiatric disorders Irritability	8.9% 4/45 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	6.6% 5/76 • Number of events 45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Psychiatric disorders Mania	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Psychiatric disorders Personality change	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Psychiatric disorders Psychiatric disorders - Other, specify	8.9% 4/45 • Number of events 9 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 9 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Psychiatric disorders Restlessness	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Psychiatric disorders Suicidal ideation	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Renal and urinary disorders Chronic kidney disease	8.9% 4/45 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 20 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 14 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Renal and urinary disorders Hematuria	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Renal and urinary disorders Proteinuria	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Renal and urinary disorders Renal and urinary disorders - Oth spec	8.9% 4/45 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Renal and urinary disorders Urinary frequency	2.2% 1/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Renal and urinary disorders Urinary incontinence	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 8 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Renal and urinary disorders Urinary retention	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Renal and urinary disorders Urinary tract pain	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Renal and urinary disorders Urinary urgency	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 8 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Reproductive system and breast disorders Dysmenorrhea	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Reproductive system and breast disorders Erectile dysfunction	2.2% 1/45 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Reproductive system and breast disorders Genital edema	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Reproductive system and breast disorders Pelvic pain	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Cough	8.9% 4/45 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	11.8% 9/76 • Number of events 14 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	27.3% 3/11 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Dyspnea	17.8% 8/45 • Number of events 22 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	21.1% 16/76 • Number of events 92 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	50.0% 3/6 • Number of events 11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	27.3% 3/11 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Hiccups	6.7% 3/45 • Number of events 17 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	7.9% 6/76 • Number of events 7 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Productive cough	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 22 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 8 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Resp, thoracic, mediastinal - Oth spec	8.9% 4/45 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Sinus pain	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Sleep apnea	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Sore throat	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	2.6% 2/76 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	27.3% 3/11 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Voice alteration	2.2% 1/45 • Number of events 16 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 8 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Skin and subcutaneous tissue disorders Dry skin	2.2% 1/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 10 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Skin and subcutaneous tissue disorders Hyperhidrosis	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 16 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	25.0% 1/4 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 13 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Skin and subcutaneous tissue disorders Pain of skin	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Skin and subcutaneous tissue disorders Pruritus	8.9% 4/45 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 23 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Skin and subcutaneous tissue disorders Rash maculo-papular	28.9% 13/45 • Number of events 22 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	17.1% 13/76 • Number of events 31 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 1/3 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	33.3% 2/6 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	27.3% 3/11 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Skin and subcutaneous tissue disorders Skin and subcut tissue disord - Oth spec	4.4% 2/45 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	6.6% 5/76 • Number of events 10 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	36.4% 4/11 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Skin and subcutaneous tissue disorders Urticaria	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/76 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Surgical and medical procedures Surgical and medical proced - Oth spec	4.4% 2/45 • Number of events 2 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Vascular disorders Flushing	6.7% 3/45 • Number of events 26 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 13 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Vascular disorders Hematoma	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Vascular disorders Hot flashes	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	5.3% 4/76 • Number of events 32 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	18.2% 2/11 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Vascular disorders Hypertension	20.0% 9/45 • Number of events 36 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	21.1% 16/76 • Number of events 103 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 5 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Vascular disorders Hypotension	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	6.6% 5/76 • Number of events 17 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Vascular disorders Phlebitis	0.00% 0/45 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	1.3% 1/76 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/11 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables
Vascular disorders Thromboembolic event	2.2% 1/45 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	3.9% 3/76 • Number of events 6 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	0.00% 0/4 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	16.7% 1/6 • Number of events 3 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables	9.1% 1/11 • Number of events 1 • 92 months All patients were included in mortality, only treated and evaluated patients are included in Adverse Events tables

Additional Information

Peter Voorhees

Levine Cancer Institute

Phone: 980-442-5219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place