Trial Outcomes & Findings for Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NCT NCT00012298)

Last Updated: 2018-08-09

Results Overview

This study is a series of 3 single-arm phase-I trials designed to determine the maximum tolerated dose (MTD) of a 2-cycle combination regimen containing Rituxan + Y2B8 radioimmunotherapy with and without the use of G-CSF and IL-11. Trial 1 will determine the Y2B8 MTD in the combined regimen without growth factors. Trial 2 will evaluate the combined regimen with growth factors. Trial 3 starts IL-11 earlier (when platelet count drops below 150000) and reduces the dosing interval to twice weekly. \> Dose-limiting toxicity (DLT) is defined as an adverse event in the second cycle attributed to treatment and meeting the following criteria: Grade 4 ANC or platelet decrease for 14 days, or grade 3 for 28 days, or any other grade 3 Non-Heme event. \> If at any time 2 or more patients (of a maximum of 6) at any dose level experience DLT, then the MTD will be defined as the previous dose level during that trial. The number of patients with a DLT are reported here.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

81 participants

Primary outcome timeframe

At 8 weeks

Results posted on

2018-08-09

Participant Flow

Phase I is a series of three single-arm trials: Trial 1 will determine the Y2B8 MTD without growth factors, Trial 2 will test the regimen with G-CSF and IL-11 added to the treatment, and Trial 3 tests different levels of IL-11 in the regimen.

Participant milestones

Participant milestones
Measure	Treatment: Trial 1, Dose Level 1 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.	Treatment: Trial 1, Dose Level 2 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.	Treatment: Trial 2, Dose Level 3 Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 2, Dose Level 4 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 3, Dose Level 5 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Treatment: Trial 3, Dose Level 6 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Treatment : Phase II (Dose Level 6) Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
Overall Study STARTED	11	7	9	4	5	6	39
Overall Study COMPLETED	11	7	9	4	5	6	39
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment: Trial 1, Dose Level 1 n=11 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.	Treatment: Trial 1, Dose Level 2 n=7 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 2, Dose Level 3 n=9 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 2, Dose Level 4 n=4 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 3, Dose Level 5 n=5 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Treatment: Trial 3, Dose Level 6 n=6 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Treatment : Phase II (Dose Level 6) n=39 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Total n=81 Participants Total of all reporting groups
Age, Continuous	60 years n=93 Participants	56 years n=4 Participants	52 years n=27 Participants	51 years n=483 Participants	46 years n=36 Participants	59 years n=10 Participants	58 years n=115 Participants	58 years n=40 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	4 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants	3 Participants n=36 Participants	1 Participants n=10 Participants	17 Participants n=115 Participants	33 Participants n=40 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants	2 Participants n=483 Participants	2 Participants n=36 Participants	5 Participants n=10 Participants	22 Participants n=115 Participants	48 Participants n=40 Participants
Region of Enrollment Saudi Arabia	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	1 participants n=483 Participants	0 participants n=36 Participants	0 participants n=10 Participants	0 participants n=115 Participants	1 participants n=40 Participants
Region of Enrollment Croatia	1 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants	0 participants n=483 Participants	0 participants n=36 Participants	0 participants n=10 Participants	0 participants n=115 Participants	1 participants n=40 Participants
Region of Enrollment United States	10 participants n=93 Participants	7 participants n=4 Participants	9 participants n=27 Participants	3 participants n=483 Participants	5 participants n=36 Participants	6 participants n=10 Participants	39 participants n=115 Participants	79 participants n=40 Participants

PRIMARY outcome

Timeframe: At 8 weeks

Population: DLTs were determined in the second cycle of combined treatment. Only Phase I patients that were evaluated after 2 cycles of treatment are included in this evaluation. Two patients at Dose Level 1, 1 patient at Dose Level 2, 4 patients at Dose Level 3, and 1 patient at Dose Level 5 were not evaluated for MTD.

Outcome measures

Outcome measures
Measure	Treatment: Trial 2, Dose Level 3 n=5 Participants Patients receive: Cycle 1: 50 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 1, Dose Level 1 n=9 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 1, Dose Level 2 n=6 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 2, Dose Level 4 n=4 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 3, Dose Level 5 n=4 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Treatment: Trial 3, Dose Level 6 n=6 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I)	0 Patients reporting Dose-Limiting Events	0 Patients reporting Dose-Limiting Events	2 Patients reporting Dose-Limiting Events	2 Patients reporting Dose-Limiting Events	0 Patients reporting Dose-Limiting Events	1 Patients reporting Dose-Limiting Events

PRIMARY outcome

Timeframe: Assessed up to week 24

Population: All patients that were evaluated for adverse events after at least one cycle of treatment were used in this analysis.

Evaluated using the Common Toxicity Criteria (CTC) version 2.0. This data is presented as the number of patients reporting grade 3 or higher, grade 4 or higher, or grade 5 adverse events regardless of event attribution.

Outcome measures

Outcome measures
Measure	Treatment: Trial 2, Dose Level 3 n=9 Participants Patients receive: Cycle 1: 50 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 1, Dose Level 1 n=11 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 1, Dose Level 2 n=7 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 2, Dose Level 4 n=4 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 3, Dose Level 5 n=5 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Treatment: Trial 3, Dose Level 6 n=6 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I) Grade 3+ Adverse Event	8 participants	9 participants	6 participants	4 participants	5 participants	6 participants
Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I) Grade 4+ Adverse Event	2 participants	2 participants	5 participants	2 participants	1 participants	1 participants
Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I) Grade 5 Adverse Event	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: At 3 years

Population: Forty-five patients were registered to Dose Level 6 (39 patients registered to the Phase II portion and 6 patients registered to Dose Level 6 in the Phase I portion). Of the 45 patients, 33 patients received 2 sequential doses of Y2B8 and were evaluable for this endpoint.

Estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated.

Outcome measures

Outcome measures
Measure	Treatment: Trial 2, Dose Level 3 Patients receive: Cycle 1: 50 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 1, Dose Level 1 n=33 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 1, Dose Level 2 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 2, Dose Level 4 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 3, Dose Level 5 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Treatment: Trial 3, Dose Level 6 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
Proportion of Patients Who Receive 2 Sequential Doses of Y2B8 Immunotherapy and Are Progression-free (Phase II)	—	.45 proportion of participants Interval 0.28 to 0.64	—	—	—	—

SECONDARY outcome

Timeframe: At week 12

Population: Not collected. Study team decision not to analyze this endpoint.

Assessed using a correlated logistic regression model and generalized estimating equations (GEE). Covariates such as dose level and use of prophylactic cytokines may also be included in this model. A Wilcoxon test will be used to assess the equality of the distributions of the continuous levels of predicted tumor radiation from the In2B8 scans by response.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At week 12

Population: Not collected. Study team decision not to analyze this endpoint.

Explored using a contingency table and sensitivity and specificity will be calculated using 90% exact confidence intervals.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At week 12

Population: Not collected. Study team decision not to analyze this endpoint.

Calculated from the serial gamma camera images. Compared using a signed-rank-test. Scatter plots will be used to further explore relationships between these residence times and Bland- Altman methods can be used to assess the agreement between the first and second In2B8 scan residence times.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From registration to death due to any cause, assessed up to 5 years

Population: Phase II portion of the study. One patient out of the 39 was deemed ineligible and was not included in survival analysis.

Estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment: Trial 2, Dose Level 3 Patients receive: Cycle 1: 50 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 1, Dose Level 1 n=38 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 1, Dose Level 2 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 2, Dose Level 4 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 3, Dose Level 5 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Treatment: Trial 3, Dose Level 6 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
Survival (Phase II)	—	NA years Interval 8.1 to Median and upper 95% confidence interval were not reached.	—	—	—	—

SECONDARY outcome

Timeframe: From registration to the earliest date documentation of>disease progression, assessed up to 5 years

Population: All eligible phase II patients. One out of the 39 phase II patients was deemed ineligible.

Estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment: Trial 2, Dose Level 3 Patients receive: Cycle 1: 50 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 1, Dose Level 1 n=38 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 1, Dose Level 2 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 2, Dose Level 4 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 3, Dose Level 5 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Treatment: Trial 3, Dose Level 6 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
Time to Disease Progression (Phase II)	—	2 years Interval 1.6 to Upper 95% confidence interval was not reached.	—	—	—	—

SECONDARY outcome

Timeframe: Assessed up to 5 years

Population: All eligible phase II patients. One of the 39 phase II patients was deemed ineligible

Calculated by the number of tumor responses divided by the total number of evaluable patients. An exact binomial confidence interval will be calculated.

Outcome measures

Outcome measures
Measure	Treatment: Trial 2, Dose Level 3 Patients receive: Cycle 1: 50 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 1, Dose Level 1 n=38 Participants Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 1, Dose Level 2 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 2, Dose Level 4 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 3, Dose Level 5 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Treatment: Trial 3, Dose Level 6 Patients receive: Cycle 1: 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8 Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1): 250 mg/m\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive: 480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500. 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
Tumor Response Rate (Phase II)	—	89.5 percentage of patients with response Interval 75.2 to 97.1	—	—	—	—

Adverse Events

Treatment: Trial 1, Dose Level 1

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Treatment: Trial 1, Dose Level 2

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Treatment: Trial 2, Dose Level 3

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Treatment: Trial 2, Dose Level 4

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Treatment: Trial 3, Dose Level 5

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Treatment: Trial 3, Dose Level 6

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Treatment : Phase II (Dose Level 6)

Serious events: 6 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment: Trial 1, Dose Level 1 n=11 participants at risk 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 1, Dose Level 2 n=7 participants at risk 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 2, Dose Level 3 n=9 participants at risk 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 2, Dose Level 4 n=4 participants at risk 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 3, Dose Level 5 n=5 participants at risk 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Treatment: Trial 3, Dose Level 6 n=6 participants at risk 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Treatment : Phase II (Dose Level 6) n=39 participants at risk 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
Blood and lymphatic system disorders Anemia	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	50.0% 2/4 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Cardiac disorders Supraventricular tachycardia	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Diarrhea	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
General disorders Fatigue	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
General disorders Pain	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Infections and infestations Infections and infestations - Other, specify	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Infections and infestations Wound infection	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Investigations Neutrophil count decreased	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	57.1% 4/7 • Number of events 21 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	22.2% 2/9 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	12.8% 5/39 • Number of events 18 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Investigations Platelet count decreased	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	28.6% 2/7 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	22.2% 2/9 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	50.0% 2/4 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	7.7% 3/39 • Number of events 15 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Investigations White blood cell decreased	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	7.7% 3/39 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Metabolism and nutrition disorders Dehydration	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Psychiatric disorders Confusion	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Renal and urinary disorders Renal and urinary disorders - Other, specify	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 1/11 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Skin and subcutaneous tissue disorders Erythema multiforme	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Vascular disorders Hypotension	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Vascular disorders Thromboembolic event	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.

Other adverse events

Other adverse events
Measure	Treatment: Trial 1, Dose Level 1 n=11 participants at risk 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 1, Dose Level 2 n=7 participants at risk 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8	Treatment: Trial 2, Dose Level 3 n=9 participants at risk 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 2, Dose Level 4 n=4 participants at risk 50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.	Treatment: Trial 3, Dose Level 5 n=5 participants at risk 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Treatment: Trial 3, Dose Level 6 n=6 participants at risk 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.	Treatment : Phase II (Dose Level 6) n=39 participants at risk 50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
Metabolism and nutrition disorders Hyperglycemia	72.7% 8/11 • Number of events 33 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	42.9% 3/7 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	44.4% 4/9 • Number of events 30 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	50.0% 2/4 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	83.3% 5/6 • Number of events 18 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	23.1% 9/39 • Number of events 30 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Metabolism and nutrition disorders Hyperkalemia	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Blood and lymphatic system disorders Anemia	90.9% 10/11 • Number of events 93 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 7/7 • Number of events 90 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 9/9 • Number of events 57 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	75.0% 3/4 • Number of events 51 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 5/5 • Number of events 33 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 6/6 • Number of events 72 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	87.2% 34/39 • Number of events 330 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 18 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Blood and lymphatic system disorders Febrile neutropenia	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Cardiac disorders Atrial flutter	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Cardiac disorders Cardiac disorders - Other, specify	9.1% 1/11 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	44.4% 4/9 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	75.0% 3/4 • Number of events 15 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	80.0% 4/5 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	33.3% 2/6 • Number of events 18 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	23.1% 9/39 • Number of events 33 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Cardiac disorders Sinus tachycardia	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Cardiac disorders Supraventricular tachycardia	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Ear and labyrinth disorders Ear pain	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Endocrine disorders Endocrine disorders - Other, specify	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Eye disorders Blurred vision	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Eye disorders Conjunctivitis	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Eye disorders Dry eye	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Eye disorders Extraocular muscle paresis	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Eye disorders Flashing lights	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Eye disorders Keratitis	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Eye disorders Watering eyes	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Abdominal pain	27.3% 3/11 • Number of events 15 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	22.2% 2/9 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	40.0% 2/5 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	12.8% 5/39 • Number of events 18 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Bloating	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Constipation	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Diarrhea	9.1% 1/11 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	22.2% 2/9 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	15.4% 6/39 • Number of events 18 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Dry mouth	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Dyspepsia	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Esophagitis	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Flatulence	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	5.1% 2/39 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Mucositis oral	18.2% 2/11 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	22.2% 2/9 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	7.7% 3/39 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Nausea	18.2% 2/11 • Number of events 18 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	71.4% 5/7 • Number of events 21 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	33.3% 3/9 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	50.0% 2/4 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	60.0% 3/5 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	33.3% 2/6 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	33.3% 13/39 • Number of events 48 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Gastrointestinal disorders Vomiting	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	22.2% 2/9 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	5.1% 2/39 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
General disorders Chills	18.2% 2/11 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	15.4% 6/39 • Number of events 18 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
General disorders Edema limbs	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
General disorders Fatigue	18.2% 2/11 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	71.4% 5/7 • Number of events 18 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	44.4% 4/9 • Number of events 15 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	40.0% 2/5 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	66.7% 4/6 • Number of events 18 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	53.8% 21/39 • Number of events 84 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
General disorders Fever	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	40.0% 2/5 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
General disorders General disorders and administration site conditions - Other, specify	18.2% 2/11 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
General disorders Injection site reaction	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	22.2% 2/9 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	5.1% 2/39 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
General disorders Non-cardiac chest pain	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	12.8% 5/39 • Number of events 15 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
General disorders Pain	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	22.2% 2/9 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	5.1% 2/39 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Immune system disorders Allergic reaction	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	33.3% 2/6 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	15.4% 6/39 • Number of events 21 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Immune system disorders Immune system disorders - Other, specify	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Infections and infestations Bladder infection	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Infections and infestations Infections and infestations - Other, specify	54.5% 6/11 • Number of events 18 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	33.3% 3/9 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	40.0% 2/5 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	50.0% 3/6 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	28.2% 11/39 • Number of events 36 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Infections and infestations Skin infection	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	5.1% 2/39 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Infections and infestations Wound infection	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Injury, poisoning and procedural complications Bruising	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	28.6% 2/7 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Injury, poisoning and procedural complications Fracture	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Investigations Alkaline phosphatase increased	27.3% 3/11 • Number of events 18 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	22.2% 2/9 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	10.3% 4/39 • Number of events 15 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Investigations Aspartate aminotransferase increased	18.2% 2/11 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	42.9% 3/7 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	33.3% 2/6 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	7.7% 3/39 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Investigations Blood bilirubin increased	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	7.7% 3/39 • Number of events 15 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Investigations Cholesterol high	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Investigations Creatinine increased	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	28.6% 2/7 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Investigations Lymphocyte count decreased	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	22.2% 2/9 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Investigations Neutrophil count decreased	81.8% 9/11 • Number of events 93 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	85.7% 6/7 • Number of events 141 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 9/9 • Number of events 147 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	75.0% 3/4 • Number of events 105 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 5/5 • Number of events 60 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 6/6 • Number of events 102 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	82.1% 32/39 • Number of events 477 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Investigations Platelet count decreased	90.9% 10/11 • Number of events 129 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 7/7 • Number of events 117 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	88.9% 8/9 • Number of events 102 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 4/4 • Number of events 84 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 5/5 • Number of events 93 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 6/6 • Number of events 126 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 39/39 • Number of events 711 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Investigations Weight gain	18.2% 2/11 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Investigations Weight loss	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Investigations White blood cell decreased	100.0% 11/11 • Number of events 135 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 7/7 • Number of events 192 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 9/9 • Number of events 180 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	75.0% 3/4 • Number of events 123 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 5/5 • Number of events 72 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	100.0% 6/6 • Number of events 93 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	87.2% 34/39 • Number of events 675 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Metabolism and nutrition disorders Anorexia	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	12.8% 5/39 • Number of events 21 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Metabolism and nutrition disorders Dehydration	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	5.1% 2/39 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Metabolism and nutrition disorders Hyperuricemia	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	33.3% 2/6 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	12.8% 5/39 • Number of events 15 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 15 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Musculoskeletal and connective tissue disorders Arthralgia	18.2% 2/11 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	33.3% 3/9 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	50.0% 3/6 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.6% 10/39 • Number of events 33 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	40.0% 2/5 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	10.3% 4/39 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Musculoskeletal and connective tissue disorders Myalgia	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	40.0% 2/5 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	50.0% 3/6 • Number of events 18 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	23.1% 9/39 • Number of events 30 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Nervous system disorders Dizziness	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	33.3% 2/6 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Nervous system disorders Dysgeusia	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Nervous system disorders Extrapyramidal disorder	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Nervous system disorders Headache	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	22.2% 2/9 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.5% 8/39 • Number of events 27 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Nervous system disorders Neuralgia	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	10.3% 4/39 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Psychiatric disorders Depression	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	28.6% 2/7 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Psychiatric disorders Insomnia	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Renal and urinary disorders Urinary frequency	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Renal and urinary disorders Urinary incontinence	9.1% 1/11 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Renal and urinary disorders Urinary tract pain	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Reproductive system and breast disorders Gynecomastia	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	5.1% 2/39 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Reproductive system and breast disorders Irregular menstruation	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	7.7% 3/39 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Respiratory, thoracic and mediastinal disorders Cough	18.2% 2/11 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	40.0% 2/5 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	50.0% 3/6 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	10.3% 4/39 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	22.2% 2/9 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	33.3% 2/6 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	5.1% 2/39 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	28.6% 2/7 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	5.1% 2/39 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	22.2% 2/9 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	50.0% 2/4 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	15.4% 6/39 • Number of events 24 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	22.2% 2/9 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	7.7% 3/39 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Skin and subcutaneous tissue disorders Rash maculo-papular	18.2% 2/11 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	33.3% 3/9 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	50.0% 2/4 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	12.8% 5/39 • Number of events 15 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	9.1% 1/11 • Number of events 6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	14.3% 1/7 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 12 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	16.7% 1/6 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	5.1% 2/39 • Number of events 9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Vascular disorders Flushing	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Vascular disorders Hot flashes	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Vascular disorders Hypertension	9.1% 1/11 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	25.0% 1/4 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Vascular disorders Phlebitis	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Vascular disorders Thromboembolic event	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	11.1% 1/9 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	20.0% 1/5 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/39 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.
Vascular disorders Vascular disorders - Other, specify	0.00% 0/11 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/7 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/9 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/4 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/5 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	0.00% 0/6 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.	2.6% 1/39 • Number of events 3 • Baseline to 30 days post treatment, up to 3 years Some of the observed Adverse Events were collected without regard to the specific Adverse Event Term, but as a general adverse event within an organ system class. These events are noted with the inclusion of "Other, specify" in the term.

Additional Information

Thomas E. Witzig, M.D.

Mayo Clinic

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60