Trial Outcomes & Findings for Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma (NCT NCT00873093)

Last Updated: 2017-01-27

Results Overview

The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

148 participants

Primary outcome timeframe

The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.

Results posted on

2017-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Pre-B ALL Relapse<36 Mths From Diagnosis (Chemo) Age>21 yr Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse 18-36 Mths From Diagnosis (Chemo) Age<=21 yr Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse<18 Mths From Diagnosis (Chemo) Age<=21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell ALL (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
Overall Study STARTED	4	62	49	23	10
Overall Study COMPLETED	3	35	33	12	8
Overall Study NOT COMPLETED	1	27	16	11	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pre-B ALL Relapse<36 Mths From Diagnosis (Chemo) Age>21 yr Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse 18-36 Mths From Diagnosis (Chemo) Age<=21 yr Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse<18 Mths From Diagnosis (Chemo) Age<=21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell ALL (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
Overall Study Adverse Event	0	2	0	0	0
Overall Study Death	0	3	2	0	0
Overall Study Physician Decision	0	17	10	10	2
Overall Study Withdrawal by Subject	1	4	4	0	0
Overall Study Ineligible	0	1	0	1	0

Baseline Characteristics

Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs n=4 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs n=62 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs n=49 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell ALL (Chemotherapy) n=23 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) n=10 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Total n=148 Participants Total of all reporting groups
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	22 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	12 Participants n=8 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	44 Participants n=7 Participants	34 Participants n=5 Participants	16 Participants n=4 Participants	8 Participants n=21 Participants	104 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	53 Participants n=7 Participants	45 Participants n=5 Participants	20 Participants n=4 Participants	8 Participants n=21 Participants	126 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	22 Participants n=8 Participants
Age, Categorical >=65 years	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
Age, Continuous	23.14 years STANDARD_DEVIATION 0.57 • n=5 Participants	10.16 years STANDARD_DEVIATION 5.77 • n=7 Participants	9.27 years STANDARD_DEVIATION 6.06 • n=5 Participants	13.00 years STANDARD_DEVIATION 5.28 • n=4 Participants	13.79 years STANDARD_DEVIATION 6.27 • n=21 Participants	10.91 years STANDARD_DEVIATION 6.23 • n=8 Participants
Gender Female	2 Participants n=5 Participants	29 Participants n=7 Participants	21 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	63 Participants n=8 Participants
Gender Male	2 Participants n=5 Participants	33 Participants n=7 Participants	28 Participants n=5 Participants	17 Participants n=4 Participants	5 Participants n=21 Participants	85 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	15 Participants n=7 Participants	18 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	38 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	44 Participants n=7 Participants	31 Participants n=5 Participants	19 Participants n=4 Participants	10 Participants n=21 Participants	107 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants

PRIMARY outcome

Timeframe: The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.

Population: The analysis on this primary outcome is limited to pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) per protocol section 9.2.1.

The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy.

Outcome measures

Outcome measures
Measure	T-cell ALL (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs n=54 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs n=46 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy	—	—	—	72.2 Percentage of participants	63 Percentage of participants

PRIMARY outcome

Timeframe: 4 months after enrollment

Population: The analysis on this primary outcome is limited to pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) per protocol section 9.2.1.

Percentage of patients who were event free at 4 months

Outcome measures

Outcome measures
Measure	T-cell ALL (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs n=54 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs n=46 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
Event Free Survival	—	—	—	68.5 Percentage of participants	37.8 Percentage of participants

PRIMARY outcome

Timeframe: 4 months

Population: The toxic death was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.

The proportion of toxic death rate among all eligible patients.

Outcome measures

Outcome measures
Measure	T-cell ALL (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs n=146 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
Toxic Death Rate	—	—	2.1 percentage of participants	—	—

PRIMARY outcome

Timeframe: 4 months

Population: The SAE event was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.

The proportion of SAE rate among all eligible patients

Outcome measures

Outcome measures
Measure	T-cell ALL (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs n=146 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
Severe Adverse Events (SAE) Rate.	—	—	8.2 percentage of participants	—	—

SECONDARY outcome

Timeframe: End of Block 1 (Day 36 of Block 1) of re-induction therapy

Population: The MRD analysis is limited to eligible and evaluable pre-B ALL with age \<= 21 years who relapsed \< 36 months only (stratum 1 \& 2) and have successful MRD determination at the end of Block 1per protocol section 9.3.3.

Percentage of eligible and evaluable patients with MRD \< 0.01% among those who had successful MRD determination at the end of Block 1.

Outcome measures

Outcome measures
Measure	T-cell ALL (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs n=48 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs n=40 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1	—	—	—	35.4 percentage of participants	25 percentage of participants

SECONDARY outcome

Timeframe: End of Block 2 (Day 36 of Block 2) of re-induction therapy

Percentage of eligible and evaluable patients with MRD \< 0.01% among those who had successful MRD determination at the end of Block 2.

Outcome measures

Outcome measures
Measure	T-cell ALL (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs n=30 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs n=19 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2	—	—	—	66.7 percentage of participants	42.1 percentage of participants

SECONDARY outcome

Timeframe: End of Block 3 (Day 36 of Block 3) of re-induction therapy

Percentage of eligible and evaluable patients with MRD \< 0.01% among those who had successful MRD determination at the end of Block 3.

Outcome measures

Outcome measures
Measure	T-cell ALL (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs n=20 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs n=11 Participants Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3	—	—	—	80 Percentage of participants	63.6 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Population: These were for correlative biology studies and the data were not collected in COG database.

NF-kB activity will be measured as a continuous variable (ng NF-kB/ug protein). Differences in NF-kB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Population: These were for correlative biology studies and the data were not collected in COG database.

Characterized using descriptive statistics. If differences are noted between pre- and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to post-treatment with bortezomib

Population: These were for correlative biology studies and the data were not collected in COG database.

Will use descriptive statistics to assess mean +/- standard deviation for stem cell percentage before and after bortezomib treatment. If there appears to be a difference in responders vs. non-responders, stem cell percentage differences between responders and non-responders will be compared using a paired t-test or equivalent nonparametric test.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to day 8 of block 2

Population: These were for correlative biology studies and the data were not collected in COG database.

Will be analyzed using descriptive statistics and will be graphically displayed by age group and stratum. PK data will be analyzed using methods such as nonlinear mixed effects modeling to estimate bortezomib clearance and volume of distribution (and the associated 95% confidence intervals) in each age group (2-11 years and 12-16 years of age).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 8 of blocks 1 and 2

This outcome measure cannot be reported due to the data used for analysis was not collected.

Outcome measures

Outcome data not reported

Adverse Events

Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs

Serious events: 47 serious events

Other events: 58 other events

Deaths: 0 deaths

Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs

Serious events: 40 serious events

Other events: 44 other events

Deaths: 0 deaths

T-cell ALL (Chemotherapy)

Serious events: 18 serious events

Other events: 21 other events

Deaths: 0 deaths

T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)

Serious events: 7 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs n=4 participants at risk Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs n=61 participants at risk Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs n=49 participants at risk Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell ALL (Chemotherapy) n=22 participants at risk Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) n=10 participants at risk Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
Cardiac disorders Ventricular tachycardia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Eye disorders Eye pain	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Anal pain	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Colitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Dental caries	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Diarrhea	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Enterocolitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Esophagitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Ileus	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Mucositis oral	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Nausea	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Blood and lymphatic system disorders Anemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	6.1% 3/49 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.1% 2/22 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Cardiac disorders Cardiac arrest	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Cardiac disorders Heart failure	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Cardiac disorders Left ventricular systolic dysfunction	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Cardiac disorders Pericardial tamponade	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Cardiac disorders Sinus bradycardia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Cardiac disorders Sinus tachycardia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Oral pain	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Pancreatic necrosis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Pancreatitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	6.1% 3/49 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	13.6% 3/22 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Peritoneal necrosis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Rectal fistula	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Typhlitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	6.6% 4/61 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.1% 2/22 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Vomiting	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
General disorders Chills	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
General disorders Death NOS	50.0% 2/4 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	39.3% 24/61 • Number of events 24 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	49.0% 24/49 • Number of events 24 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	40.9% 9/22 • Number of events 9 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	50.0% 5/10 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
General disorders Fever	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
General disorders Flu like symptoms	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
General disorders Hypothermia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
General disorders Multi-organ failure	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
General disorders Pain	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Immune system disorders Allergic reaction	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Immune system disorders Cytokine release syndrome	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Appendicitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Appendicitis perforated	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Catheter related infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Encephalitis infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Enterocolitis infectious	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	8.2% 5/61 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	6.1% 3/49 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.1% 2/22 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Infective myositis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Joint infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Lung infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Mucosal infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Papulopustular rash	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Pharyngitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Sepsis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	13.1% 8/61 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	16.3% 8/49 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.1% 2/22 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Sinusitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Soft tissue infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Urinary tract infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Alanine aminotransferase increased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Aspartate aminotransferase increased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Blood bilirubin increased	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.1% 2/22 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Cholesterol high	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Creatinine increased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Investigations - Other, specify	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Lipase increased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	13.6% 3/22 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Neutrophil count decreased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Platelet count decreased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Serum amylase increased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations White blood cell decreased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Acidosis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Anorexia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.1% 2/22 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.1% 2/22 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	13.1% 8/61 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	6.6% 4/61 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	8.2% 4/49 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	8.2% 4/49 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.1% 2/22 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Akathisia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Depressed level of consciousness	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Dysarthria	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Encephalopathy	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Headache	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Memory impairment	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Neuralgia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Paresthesia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Peripheral sensory neuropathy	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Reversible posterior leukoencephalopathy syndrome	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Seizure	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Stroke	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Syncope	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Psychiatric disorders Anxiety	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Psychiatric disorders Confusion	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Psychiatric disorders Psychiatric disorders - Other, specify	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Renal and urinary disorders Acute kidney injury	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Renal and urinary disorders Urinary retention	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	6.1% 3/49 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	13.1% 8/61 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	6.1% 3/49 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	8.2% 5/61 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	8.2% 4/49 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Vascular disorders Capillary leak syndrome	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Vascular disorders Hypertension	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Vascular disorders Hypotension	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	13.1% 8/61 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.2% 5/49 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	13.6% 3/22 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.

Other adverse events

Other adverse events
Measure	Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs n=4 participants at risk Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs n=61 participants at risk Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs n=49 participants at risk Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell ALL (Chemotherapy) n=22 participants at risk Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.	T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) n=10 participants at risk Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
Metabolism and nutrition disorders Anorexia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.8% 6/61 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	6.1% 3/49 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Blood and lymphatic system disorders Anemia	75.0% 3/4 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	67.2% 41/61 • Number of events 47 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	55.1% 27/49 • Number of events 29 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	77.3% 17/22 • Number of events 17 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	70.0% 7/10 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	37.7% 23/61 • Number of events 23 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	44.9% 22/49 • Number of events 22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	45.5% 10/22 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	20.0% 2/10 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Cardiac disorders Pericardial effusion	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Cardiac disorders Ventricular tachycardia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Eye disorders Conjunctivitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Abdominal distension	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Abdominal pain	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Anal fistula	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Anal pain	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Ascites	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Colitis	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Diarrhea	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	6.6% 4/61 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Enterocolitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Ileus	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Mucositis oral	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	11.5% 7/61 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	8.2% 4/49 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Nausea	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Oral pain	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Pancreatitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Proctitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Rectal pain	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.1% 2/22 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Rectal ulcer	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Typhlitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
General disorders Facial pain	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
General disorders Fatigue	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
General disorders Fever	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	13.1% 8/61 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	6.1% 3/49 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
General disorders Infusion related reaction	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
General disorders Pain	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Anorectal infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Appendicitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Bladder infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Bronchial infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Catheter related infection	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	18.0% 11/61 • Number of events 12 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	16.3% 8/49 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	18.2% 4/22 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Conjunctivitis infective	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Enterocolitis infectious	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Eye infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Hepatic infection	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Infections and infestations - Other, specify	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	32.8% 20/61 • Number of events 22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	30.6% 15/49 • Number of events 16 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	31.8% 7/22 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	40.0% 4/10 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Kidney infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Lung infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.8% 6/61 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	20.0% 2/10 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Nail infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Paronychia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Periorbital infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Peritoneal infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Sepsis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.8% 6/61 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.2% 5/49 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.1% 2/22 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Sinusitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Skin infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	20.0% 2/10 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Soft tissue infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Splenic infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Urinary tract infection	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	8.2% 5/61 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Infections and infestations Wound infection	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Injury, poisoning and procedural complications Postoperative hemorrhage	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Alanine aminotransferase increased	50.0% 2/4 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	24.6% 15/61 • Number of events 15 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	16.3% 8/49 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	13.6% 3/22 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	30.0% 3/10 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Alkaline phosphatase increased	50.0% 2/4 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Aspartate aminotransferase increased	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	13.1% 8/61 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	8.2% 4/49 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	13.6% 3/22 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	20.0% 2/10 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Blood bilirubin increased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Creatinine increased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Ejection fraction decreased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Fibrinogen decreased	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	20.0% 2/10 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Forced expiratory volume decreased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations GGT increased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Investigations - Other, specify	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Lipase increased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	11.5% 7/61 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	6.1% 3/49 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Lymphocyte count decreased	50.0% 2/4 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	26.2% 16/61 • Number of events 19 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	32.7% 16/49 • Number of events 21 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	22.7% 5/22 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	20.0% 2/10 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	13.6% 3/22 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Lymphocyte count increased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Neutrophil count decreased	75.0% 3/4 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	63.9% 39/61 • Number of events 45 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	61.2% 30/49 • Number of events 34 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	81.8% 18/22 • Number of events 20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	90.0% 9/10 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Platelet count decreased	75.0% 3/4 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	72.1% 44/61 • Number of events 50 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	65.3% 32/49 • Number of events 39 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	81.8% 18/22 • Number of events 20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	90.0% 9/10 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Serum amylase increased	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations Weight loss	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Investigations White blood cell decreased	75.0% 3/4 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	62.3% 38/61 • Number of events 44 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	59.2% 29/49 • Number of events 31 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	54.5% 12/22 • Number of events 15 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	70.0% 7/10 • Number of events 9 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Acidosis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hyperglycemia	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	16.4% 10/61 • Number of events 11 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.2% 5/49 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	13.6% 3/22 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hyperkalemia	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.1% 2/49 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypoalbuminemia	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	12.2% 6/49 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	13.6% 3/22 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	20.0% 2/10 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypocalcemia	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	11.5% 7/61 • Number of events 9 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.2% 5/49 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypokalemia	50.0% 2/4 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	24.6% 15/61 • Number of events 16 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	26.5% 13/49 • Number of events 14 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	27.3% 6/22 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	30.0% 3/10 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.8% 6/61 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	8.2% 4/49 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	11.5% 7/61 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.2% 5/49 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	30.0% 3/10 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Dizziness	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Headache	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	9.1% 2/22 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Syncope	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Nervous system disorders Tremor	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Psychiatric disorders Agitation	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Psychiatric disorders Anxiety	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Psychiatric disorders Confusion	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Psychiatric disorders Delirium	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Psychiatric disorders Depression	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Psychiatric disorders Psychosis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.9% 3/61 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Epistaxis	25.0% 1/4 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	10.0% 1/10 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	3.3% 2/61 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Vascular disorders Capillary leak syndrome	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	1.6% 1/61 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Vascular disorders Hematoma	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	2.0% 1/49 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Vascular disorders Hypertension	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	8.2% 5/61 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	20.0% 2/10 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
Vascular disorders Hypotension	0.00% 0/4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	6.6% 4/61 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	12.2% 6/49 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	4.5% 1/22 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.	0.00% 0/10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60