Trial Outcomes & Findings for Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer (NCT NCT00011986)

NCT ID: NCT00011986

Last Updated: 2019-04-16

Results Overview

Proportion of participants whose overall survival exceeded 5 years.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

4312 participants

Primary outcome timeframe

Up to 9 years

Results posted on

2019-04-16

Participant Flow

Received began 1/29/2001 and ended 1/28/2003. This was an interventional trial involving patients enrolled from the United States (US), Canada, United Kingdom (UK), Italy, Australia, and New Zealand.

This study involved patients enrolled from two cooperative groups with the plan to combine data. 3882 patients were enrolled from one cooperative group and 430 from the other. This report includes those patients from both groups.

Participant milestones

Participant milestones
Measure	Carbo/Taxol Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles	Carbo/Taxol/Gemcitabine Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles	Carbo/Taxol/Doxil Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles	Carbo/Topotecan - Carbo/Taxol Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles	Carbo/Gemcitabine - Carbo/Taxol Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
Overall Study STARTED	864	864	862	861	861
Overall Study Initiated Treatment	862	860	854	846	851
Overall Study COMPLETED	864	864	862	861	861
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carbo/Taxol n=864 Participants Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles	Carbo/Taxol/Gemcitabine n=864 Participants Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles	Carbo/Taxol/Doxil n=862 Participants Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles	Carbo/Topotecan - Carbo/Taxol n=861 Participants Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles	Carbo/Gemcitabine - Carbo/Taxol n=861 Participants Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles	Total n=4312 Participants Total of all reporting groups
Age, Continuous	57.8 years STANDARD_DEVIATION 11.1 • n=5 Participants	58.8 years STANDARD_DEVIATION 10.8 • n=7 Participants	59.0 years STANDARD_DEVIATION 11.1 • n=5 Participants	58.2 years STANDARD_DEVIATION 11.0 • n=4 Participants	58.9 years STANDARD_DEVIATION 10.7 • n=21 Participants	58.6 years STANDARD_DEVIATION 10.9 • n=8 Participants
Sex: Female, Male Female	864 Participants n=5 Participants	864 Participants n=7 Participants	862 Participants n=5 Participants	861 Participants n=4 Participants	861 Participants n=21 Participants	4312 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
International Federation of Gynecology and Obstetrics (FIGO) Stage Stage III:see description for details	724 participants n=5 Participants	749 participants n=7 Participants	743 participants n=5 Participants	744 participants n=4 Participants	721 participants n=21 Participants	3681 participants n=8 Participants
International Federation of Gynecology and Obstetrics (FIGO) Stage Stage IV:see description for details	140 participants n=5 Participants	115 participants n=7 Participants	119 participants n=5 Participants	117 participants n=4 Participants	140 participants n=21 Participants	631 participants n=8 Participants
Primary Site of Disease Ovary	748 participants n=5 Participants	752 participants n=7 Participants	737 participants n=5 Participants	752 participants n=4 Participants	751 participants n=21 Participants	3740 participants n=8 Participants
Primary Site of Disease Peritoneum	116 participants n=5 Participants	112 participants n=7 Participants	125 participants n=5 Participants	109 participants n=4 Participants	110 participants n=21 Participants	572 participants n=8 Participants
Size of Residual Disease Microscopic only	197 participants n=5 Participants	218 participants n=7 Participants	206 participants n=5 Participants	220 participants n=4 Participants	203 participants n=21 Participants	1044 participants n=8 Participants
Size of Residual Disease ≤ 1 cm gross disease	404 participants n=5 Participants	384 participants n=7 Participants	405 participants n=5 Participants	358 participants n=4 Participants	398 participants n=21 Participants	1949 participants n=8 Participants
Size of Residual Disease > 1 cm gross disease	263 participants n=5 Participants	262 participants n=7 Participants	251 participants n=5 Participants	283 participants n=4 Participants	260 participants n=21 Participants	1319 participants n=8 Participants

PRIMARY outcome

Timeframe: Up to 9 years

Population: All enrolled participants.

Proportion of participants whose overall survival exceeded 5 years.

Outcome measures

Outcome measures
Measure	Carbo/Taxol n=864 Participants Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles	Carbo/Taxol/Gemcitabine n=864 Participants Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles	Carbo/Taxol/Doxil n=862 Participants Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles	Carbo/Topotecan - Carbo/Taxol n=861 Participants Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles	Carbo/Gemcitabine - Carbo/Taxol n=861 Participants Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
Overall Survival	0.35 Proportion of participants	0.34 Proportion of participants	0.39 Proportion of participants	0.34 Proportion of participants	0.30 Proportion of participants

PRIMARY outcome

Timeframe: From the date of enrollment to first progression or death or last contact, if alive and progression free.

Median duration in months of progression free survival.

Outcome measures

Outcome measures
Measure	Carbo/Taxol n=864 Participants Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles	Carbo/Taxol/Gemcitabine n=864 Participants Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles	Carbo/Taxol/Doxil n=862 Participants Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles	Carbo/Topotecan - Carbo/Taxol n=861 Participants Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles	Carbo/Gemcitabine - Carbo/Taxol n=861 Participants Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
Progression-free Survival	16.0 months Interval 14.9 to 17.2	16.3 months Interval 15.1 to 17.7	16.4 months Interval 15.3 to 17.5	15.4 months Interval 14.7 to 16.3	15.4 months Interval 14.6 to 16.4

SECONDARY outcome

Timeframe: Up to 9 years

Population: Eligible and treated participants

Outcome measures

Outcome measures
Measure	Carbo/Taxol n=862 Participants Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles	Carbo/Taxol/Gemcitabine n=860 Participants Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles	Carbo/Taxol/Doxil n=854 Participants Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles	Carbo/Topotecan - Carbo/Taxol n=846 Participants Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles	Carbo/Gemcitabine - Carbo/Taxol n=851 Participants Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Pain	53 Participants	75 Participants	75 Participants	66 Participants	52 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Leukopenia	438 Participants	686 Participants	595 Participants	476 Participants	513 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Neutropenia	749 Participants	798 Participants	782 Participants	779 Participants	761 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Thrombocytopenia	193 Participants	520 Participants	320 Participants	303 Participants	486 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Anemia	102 Participants	196 Participants	160 Participants	167 Participants	203 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Other Hematologic	156 Participants	338 Participants	244 Participants	246 Participants	315 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Allergy	38 Participants	20 Participants	28 Participants	21 Participants	26 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Auditory	5 Participants	2 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Cardiovascular	20 Participants	36 Participants	34 Participants	17 Participants	23 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Coagulation	5 Participants	10 Participants	4 Participants	9 Participants	7 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Constitutional	54 Participants	96 Participants	84 Participants	73 Participants	57 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Dermatologic	13 Participants	6 Participants	11 Participants	6 Participants	8 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Endocrine	0 Participants	4 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Gastrointestinal	90 Participants	145 Participants	124 Participants	105 Participants	92 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Genitourinary/Renal	9 Participants	8 Participants	13 Participants	6 Participants	9 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Hemorrhage	8 Participants	29 Participants	20 Participants	8 Participants	30 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Hepatic	13 Participants	32 Participants	11 Participants	13 Participants	25 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Infection/Fever	76 Participants	138 Participants	134 Participants	84 Participants	82 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Metabolic	61 Participants	55 Participants	55 Participants	37 Participants	45 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Musculoskeletal	7 Participants	18 Participants	13 Participants	8 Participants	10 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Neurologic	34 Participants	47 Participants	43 Participants	28 Participants	35 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Peripheral Neurologic	45 Participants	59 Participants	45 Participants	35 Participants	24 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Ocular/Visual	1 Participants	3 Participants	1 Participants	3 Participants	3 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Pulmonary	19 Participants	37 Participants	39 Participants	21 Participants	37 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Sexual	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Observed Adverse Effects (Grade 3 and Above) Assessed by Common Toxicity Criteria Version 2.0 Second Primary	34 Participants	66 Participants	51 Participants	41 Participants	57 Participants

Adverse Events

Carbo/Taxol

Serious events: 86 serious events

Other events: 857 other events

Deaths: 0 deaths

Carbo/Taxol/Gemcitabine

Serious events: 107 serious events

Other events: 856 other events

Deaths: 0 deaths

Carbo/Taxol/Doxil

Serious events: 115 serious events

Other events: 852 other events

Deaths: 0 deaths

Carbo/Topotecan - Carbo/Taxol

Serious events: 77 serious events

Other events: 843 other events

Deaths: 0 deaths

Carbo/Gemcitabine - Carbo/Taxol

Serious events: 100 serious events

Other events: 849 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Carbo/Taxol n=862 participants at risk；n=777 participants at risk Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles	Carbo/Taxol/Gemcitabine n=860 participants at risk；n=774 participants at risk Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles	Carbo/Taxol/Doxil n=854 participants at risk；n=767 participants at risk Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles	Carbo/Topotecan - Carbo/Taxol n=846 participants at risk；n=766 participants at risk Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles	Carbo/Gemcitabine - Carbo/Taxol n=851 participants at risk；n=767 participants at risk Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
Immune system disorders Allergy-Other	0.51% 4/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Immune system disorders Allergic Reaction/Hypersensitivity	1.2% 9/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.78% 6/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.78% 6/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.78% 6/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Ear and labyrinth disorders Inner Ear/Hearing	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Ear and labyrinth disorders Hearing-Other	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Blood and lymphatic system disorders Hemoglobin	0.26% 2/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Blood and lymphatic system disorders Platelets	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.6% 12/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.0% 8/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Blood and lymphatic system disorders Neutrophils/Granulocytes	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Blood and lymphatic system disorders Leukocytes	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Hypertension	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Circulatory Or Cardiac-Other	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Cardiac Left Ventricular Function	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Cardiac Troponin I	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Hypotension	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Sinus Tachycardia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Phlebitis	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Vasovagal Episode	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Supraventricular Arrhythmias	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Thrombosis/Embolism	1.3% 10/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.2% 9/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.7% 13/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.7% 13/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	2.1% 16/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Nodal/Junctional Arrhythmia/Dysrhythmia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Arrhythmia- Other	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Cardiac-Ischemia/Infarction	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Sinus Bradycardia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Edema	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
General disorders Constitutional Symptoms-Other	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
General disorders Fever In The Absence Of Neutropenia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
General disorders Fatigue	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Skin and subcutaneous tissue disorders Pruritus	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Skin and subcutaneous tissue disorders Wound-Infectious	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Skin and subcutaneous tissue disorders Rash/Desquamation	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Skin and subcutaneous tissue disorders Skin-Other	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Skin and subcutaneous tissue disorders Wound-Non-Infectious	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Skin and subcutaneous tissue disorders Erythema Multiforme	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Stomatitis/Pharyngitis	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Pancreatitis	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Gi-Other	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Ileus	0.64% 5/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.52% 4/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.52% 4/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.65% 5/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Gastritis	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Anorexia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Dyspepsia/Heartburn	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Gastric Ulcer	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Colitis	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Ascites (Non-Malignant)	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Fistula-Rectal/Anal	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Dehydration	0.26% 2/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Constipation	0.77% 6/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.90% 7/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.65% 5/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Diarrhea (Without Colostomy)	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.52% 4/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Vomiting	0.90% 7/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.0% 8/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.4% 11/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.91% 7/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Nausea	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Vascular disorders Hemorrhage-Other	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Vascular disorders Rectal Bleeding/Hematochezia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Vascular disorders Hemorrhage/Bleeding Associated With Surgery	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Vascular disorders Epistaxis	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Vascular disorders Hemorrhage/Bleeding With Grade 3 Or 4 Th	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Vascular disorders Hematuria (In The Absence Of Vaginal Bleeding	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Hepatobiliary disorders Hepatic-Other	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Hepatobiliary disorders Sgpt	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Hepatobiliary disorders Sgot	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Hepatobiliary disorders Bilirubin	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Infections and infestations Infection, Other	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Infections and infestations Catheter-Related Infection	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Infections and infestations Infection With Unknown Anc	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Infections and infestations Infection Documented W Grd 3/4 Neutropn.	0.64% 5/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.2% 9/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	2.0% 15/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.91% 7/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.52% 4/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Infections and infestations Infection Without Neutropenia	0.90% 7/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.0% 8/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.65% 5/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.78% 6/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.78% 6/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Infections and infestations Febrile Neutropenia-Fuo Infect Not Docum	1.0% 8/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.6% 12/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	2.0% 15/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.3% 10/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.91% 7/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Metabolism and nutrition disorders Metabolic-Other	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Metabolism and nutrition disorders Hypomagnesmia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Musculoskeletal and connective tissue disorders Joint, Muscle, Or Bone-Other	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Nervous system disorders Tremor	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Nervous system disorders Speech Impairment- Dysphasia/Aphasia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Nervous system disorders Seizure(S)	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Nervous system disorders Hallucinations	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Nervous system disorders Cns Cerebrovascular Ischemia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.52% 4/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Nervous system disorders Confusion	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Nervous system disorders Syncope	0.77% 6/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.65% 5/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Nervous system disorders Mood Alteration-Anxiety Agitation	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Nervous system disorders Dizziness/Lightheadedness	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Nervous system disorders Neuropathy-Sensory	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Nervous system disorders Neuropathy Motor	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Eye disorders Glaucoma	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
General disorders Chest Pain Non-Cardiac Or Non-Pleuritic	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
General disorders Headache	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
General disorders Abdominal Pain Or Cramping	0.51% 4/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.52% 4/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
General disorders Bone Pain	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
General disorders Arthralgia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
General disorders Myalgia	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
General disorders Pain-Other	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Respiratory, thoracic and mediastinal disorders Pleural Effusion (Non-Malignant)	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.52% 4/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.39% 3/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Respiratory, thoracic and mediastinal disorders Adult Respiratory Distress Syndrome	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Renal and urinary disorders Operative Injury To Bladder/Ureter	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Renal and urinary disorders Fistula Or Gu Fistula	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Renal and urinary disorders Renal Failure	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.26% 2/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Renal and urinary disorders Creatinine	0.13% 1/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Renal and urinary disorders Renal/Gu-Other	0.00% 0/777 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/774 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.00% 0/766 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.13% 1/767 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.

Other adverse events

Other adverse events
Measure	Carbo/Taxol n=862 participants at risk；n=777 participants at risk Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles	Carbo/Taxol/Gemcitabine n=860 participants at risk；n=774 participants at risk Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles	Carbo/Taxol/Doxil n=854 participants at risk；n=767 participants at risk Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles	Carbo/Topotecan - Carbo/Taxol n=846 participants at risk；n=766 participants at risk Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles	Carbo/Gemcitabine - Carbo/Taxol n=851 participants at risk；n=767 participants at risk Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
Blood and lymphatic system disorders Neutropenia	95.2% 821/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	97.4% 838/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	95.8% 818/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	98.1% 830/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	96.9% 825/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Blood and lymphatic system disorders Leukopenia	86.5% 746/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	96.0% 826/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	94.4% 806/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	92.4% 782/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	94.0% 800/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Blood and lymphatic system disorders Thrombocytopenia	37.0% 319/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	78.5% 675/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	51.3% 438/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	54.4% 460/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	75.8% 645/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Blood and lymphatic system disorders Anemia	58.9% 508/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	81.4% 700/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	70.6% 603/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	76.5% 647/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	80.5% 685/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Blood and lymphatic system disorders Other Hemotologic	19.0% 164/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	40.8% 351/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	30.6% 261/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	30.7% 260/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	38.4% 327/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Immune system disorders Allergy	7.5% 65/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	4.9% 42/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	6.3% 54/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	4.6% 39/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	5.5% 47/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Ear and labyrinth disorders Auditory	2.6% 22/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	2.3% 20/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	2.7% 23/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	2.0% 17/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.8% 15/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Cardiac disorders Cardiovascular	5.0% 43/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	8.4% 72/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	7.3% 62/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	4.3% 36/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	7.2% 61/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Vascular disorders Coagulation	1.2% 10/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.4% 12/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.70% 6/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.7% 14/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.2% 10/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
General disorders Constitutional	42.3% 365/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	50.5% 434/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	47.2% 403/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	43.4% 367/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	42.7% 363/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Skin and subcutaneous tissue disorders Dermatologic	7.3% 63/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	7.1% 61/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	12.8% 109/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	5.6% 47/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	7.5% 64/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Endocrine disorders Endocrine	4.2% 36/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	4.4% 38/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	4.8% 41/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	4.7% 40/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	3.2% 27/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Gastrointestinal disorders Gastrointestinal	48.8% 421/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	54.5% 469/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	58.1% 496/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	47.6% 403/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	46.9% 399/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Renal and urinary disorders Genitourinary/Renal	5.3% 46/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	6.2% 53/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	6.6% 56/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	4.3% 36/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	4.9% 42/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Blood and lymphatic system disorders Hemorrhage	1.6% 14/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	4.8% 41/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	3.9% 33/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	2.1% 18/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	5.9% 50/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Hepatobiliary disorders Hepatic	5.0% 43/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	11.2% 96/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	4.9% 42/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	4.6% 39/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	9.3% 79/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Infections and infestations Infection/Fever	15.7% 135/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	22.8% 196/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	23.3% 199/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	16.9% 143/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	17.3% 147/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Metabolism and nutrition disorders Metabolic	13.7% 118/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	11.4% 98/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	12.5% 107/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	9.3% 79/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	11.4% 97/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Musculoskeletal and connective tissue disorders Musculoskeletal	6.4% 55/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	7.2% 62/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	6.1% 52/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	5.2% 44/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	5.3% 45/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Nervous system disorders Neurologic	13.6% 117/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	15.7% 135/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	12.9% 110/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	10.6% 90/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	14.0% 119/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Nervous system disorders Peripheral neurologic	24.0% 207/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	27.0% 232/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	24.2% 207/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	15.8% 134/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	16.9% 144/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Eye disorders Ocular/Visual	4.9% 42/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	6.3% 54/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	7.5% 64/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	3.3% 28/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	4.5% 38/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
General disorders Pain	36.8% 317/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	35.0% 301/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	34.4% 294/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	34.9% 295/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	34.0% 289/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Respiratory, thoracic and mediastinal disorders Pulmonary	12.1% 104/861 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	15.0% 129/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	13.8% 118/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	12.5% 106/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	17.0% 145/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Reproductive system and breast disorders Sexual	0.46% 4/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.0% 9/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	1.3% 11/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.71% 6/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	0.59% 5/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 2nd Primary	8.1% 70/862 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	10.9% 94/860 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	10.0% 85/854 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	8.7% 74/846 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.	10.0% 85/851 • From date of enrollment onto the study to 30 days after last treatment cycle or any Adverse Event (AE) considered to be due to study treatment regardless of when it occurred. Only Serious Adverse Events(SAE) for the US-enrolled participants is able to be reported. Due to the methods in which AEs were collected \&/or stored, it is not possible to report only the Other(not including Serious) AEs in the appropriate table. Therefore that table is a combined set of SAEs \& non-serious AEs. Other AEs are Grade 2 or worse.

Additional Information

Linda Gedeon, BS, CCRP

Gynecologic Oncology Group Statistical and Data Center

Phone: 716-845-1169

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place