Trial Outcomes & Findings for Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes (NCT NCT00096135)

NCT ID: NCT00096135

Last Updated: 2017-03-21

Results Overview

Monitoring of efficacy results will be performed in comparison with historical results.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 168 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2017-03-21

Participant Flow

Participant milestones

Measure	CNS Patients - Treatment (Combination Chemotherapy) All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.	Testicular Relapse Patients (Combination Chemotherapy) All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.
Overall Study STARTED	126	42
Overall Study COMPLETED	63	27
Overall Study NOT COMPLETED	63	15

Reasons for withdrawal

Measure	CNS Patients - Treatment (Combination Chemotherapy) All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.	Testicular Relapse Patients (Combination Chemotherapy) All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.
Overall Study Physician Decision	20	4
Overall Study Refusal of further protocol therapy	4	1
Overall Study Progressive disease, Marrow,CNS, Relapse	22	7
Overall Study Other, specify	15	3
Overall Study Ineligible	2	0

Baseline Characteristics

Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes

Baseline characteristics by cohort

Measure	CNS Patients - Treatment (Combination Chemotherapy) n=124 Participants All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.	Testicular Relapse Patients (Combination Chemotherapy) n=42 Participants All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.	Total n=166 Participants Total of all reporting groups
Age, Categorical <=18 years	118 Participants n=5 Participants	42 Participants n=7 Participants	160 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	8.2 years STANDARD_DEVIATION 4.8 • n=5 Participants	9.2 years STANDARD_DEVIATION 3.2 • n=7 Participants	8.5 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	0 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	42 Participants n=7 Participants	130 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=5 Participants	10 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	87 Participants n=5 Participants	30 Participants n=7 Participants	117 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	91 Participants n=5 Participants	33 Participants n=7 Participants	124 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	6 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: The CNS-treatment cohort includes 126 patients with 120 CNS pre-B, 2 CNS+ITR pre-B and 4 T-AL. The primary analysis was restricted to CNS pre-B and ITR pre-B patients, respectively. Both CNS+ITR and T-ALL patients had to be excluded from the primary analysis. That is how we came to 120 in the CNS-treatment cohort for outcome analysis.

Monitoring of efficacy results will be performed in comparison with historical results.

Outcome measures

Measure	CNS Patients - Treatment (Combination Chemotherapy) n=120 Participants All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.	Testicular Relapse Patients (Combination Chemotherapy) n=40 Participants All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.
Event-free Survival	64.9 percentage of participants	70 percentage of participants

Adverse Events

CNS Patients - Treatment (Combination Chemotherapy)

Serious events: 7 serious events

Other events: 119 other events

Deaths: 0 deaths

Testicular Relapse Patients (Combination Chemotherapy)

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Measure	CNS Patients - Treatment (Combination Chemotherapy) n=124 participants at risk All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.	Testicular Relapse Patients (Combination Chemotherapy) n=42 participants at risk All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Cardiac disorders Cardiac disorders - Other	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
General disorders Death NOS	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Hepatobiliary disorders Hepatic failure	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Infections and infestations - Other	4.8% 6/124 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Lung infection	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Activated partial thromboplastin time prolonged	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Alanine aminotransferase increased	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Aspartate aminotransferase increased	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Blood bilirubin increased	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Fibrinogen decreased	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations GGT increased	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations INR increased	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Platelet count decreased	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations White blood cell decreased	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Acidosis	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Hyperglycemia	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Hyponatremia	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Vascular disorders Thromboembolic event	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.

Other adverse events

Measure	CNS Patients - Treatment (Combination Chemotherapy) n=124 participants at risk All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.	Testicular Relapse Patients (Combination Chemotherapy) n=42 participants at risk All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride \& intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide \& ITT.
Investigations GGT increased	4.8% 6/124 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Investigations - Other	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Lipase increased	7.3% 9/124 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Lymphocyte count decreased	2.4% 3/124 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Neutrophil count decreased	79.0% 98/124 • Number of events 130 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	78.6% 33/42 • Number of events 42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Platelet count decreased	58.9% 73/124 • Number of events 97 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	38.1% 16/42 • Number of events 23 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Serum amylase increased	3.2% 4/124 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Weight gain	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations White blood cell decreased	50.8% 63/124 • Number of events 93 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	33.3% 14/42 • Number of events 19 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Anorexia	4.0% 5/124 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	7.1% 3/42 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Dehydration	6.5% 8/124 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	14.3% 6/42 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Glucose intolerance	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Hyperglycemia	7.3% 9/124 • Number of events 9 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	11.9% 5/42 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Hyperkalemia	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Hypertriglyceridemia	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Hypoalbuminemia	2.4% 3/124 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Hypocalcemia	4.8% 6/124 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Hypoglycemia	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Hypokalemia	24.2% 30/124 • Number of events 35 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	21.4% 9/42 • Number of events 9 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Hypomagnesemia	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Hyponatremia	9.7% 12/124 • Number of events 12 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	7.1% 3/42 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Metabolism and nutrition disorders Hypophosphatemia	3.2% 4/124 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Arthralgia	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Avascular necrosis	2.4% 3/124 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Back pain	4.8% 6/124 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Bone pain	2.4% 3/124 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.6% 7/124 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	4.8% 2/42 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Myalgia	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Myositis	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/124 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Musculoskeletal and connective tissue disorders Pain in extremity	4.0% 5/124 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	7.1% 3/42 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Nervous system disorders Ataxia	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Nervous system disorders Cognitive disturbance	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Nervous system disorders Depressed level of consciousness	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Nervous system disorders Dizziness	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Nervous system disorders Dysphasia	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Nervous system disorders Headache	5.6% 7/124 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Nervous system disorders Memory impairment	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Nervous system disorders Neuralgia	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Nervous system disorders Peripheral motor neuropathy	7.3% 9/124 • Number of events 9 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	4.8% 2/42 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Nervous system disorders Peripheral sensory neuropathy	6.5% 8/124 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	7.1% 3/42 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Nervous system disorders Seizure	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Nervous system disorders Sinus pain	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Nervous system disorders Syncope	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Psychiatric disorders Agitation	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Psychiatric disorders Anxiety	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Psychiatric disorders Confusion	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Psychiatric disorders Depression	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Psychiatric disorders Insomnia	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Psychiatric disorders Personality change	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Psychiatric disorders Psychosis	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Renal and urinary disorders Acute kidney injury	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Renal and urinary disorders Proteinuria	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Renal and urinary disorders Renal calculi	0.00% 0/124 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Renal and urinary disorders Urinary tract obstruction	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Renal and urinary disorders Urinary tract pain	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Reproductive system and breast disorders Penile pain	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Reproductive system and breast disorders Perineal pain	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Reproductive system and breast disorders Vaginal inflammation	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Apnea	0.00% 0/124 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Cough	3.2% 4/124 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/124 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.4% 3/124 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Hiccups	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.2% 4/124 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Blood and lymphatic system disorders Anemia	41.9% 52/124 • Number of events 65 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	28.6% 12/42 • Number of events 15 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Blood and lymphatic system disorders Febrile neutropenia	65.3% 81/124 • Number of events 86 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	64.3% 27/42 • Number of events 30 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Cardiac disorders Sinus tachycardia	0.00% 0/124 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Ear and labyrinth disorders Middle ear inflammation	2.4% 3/124 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Eye disorders Extraocular muscle paresis	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Eye disorders Eye disorders - Other	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Eye disorders Photophobia	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Abdominal pain	5.6% 7/124 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Anal mucositis	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Anal pain	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Colitis	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Constipation	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Diarrhea	9.7% 12/124 • Number of events 12 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	11.9% 5/42 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Dyspepsia	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Esophagitis	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Gastrointestinal disorders - Other	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Ileus	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Mucositis oral	12.1% 15/124 • Number of events 15 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	9.5% 4/42 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Nausea	5.6% 7/124 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	4.8% 2/42 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Oral pain	4.0% 5/124 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Pancreatitis	3.2% 4/124 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	4.8% 2/42 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Rectal mucositis	0.00% 0/124 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Rectal pain	2.4% 3/124 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Stomach pain	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Typhlitis	0.00% 0/124 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Gastrointestinal disorders Vomiting	6.5% 8/124 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
General disorders Death NOS	0.00% 0/124 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
General disorders Fatigue	2.4% 3/124 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
General disorders Fever	10.5% 13/124 • Number of events 13 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	14.3% 6/42 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
General disorders Flu like symptoms	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
General disorders General disorders and administration site conditions - Other	2.4% 3/124 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
General disorders Multi-organ failure	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
General disorders Pain	4.8% 6/124 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
General disorders Sudden death NOS	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Hepatobiliary disorders Hepatic failure	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Immune system disorders Allergic reaction	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Immune system disorders Anaphylaxis	8.9% 11/124 • Number of events 11 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	16.7% 7/42 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Immune system disorders Cytokine release syndrome	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Immune system disorders Immune system disorders - Other	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Immune system disorders Serum sickness	0.00% 0/124 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Abdominal infection	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Anorectal infection	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Arteritis infective	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Bladder infection	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Bronchial infection	0.00% 0/124 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Catheter related infection	8.1% 10/124 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	7.1% 3/42 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Enterocolitis infectious	4.8% 6/124 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Eye infection	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Gum infection	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Infections and infestations - Other	66.1% 82/124 • Number of events 90 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	54.8% 23/42 • Number of events 25 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Joint infection	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Lung infection	8.1% 10/124 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	4.8% 2/42 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Meningitis	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Mucosal infection	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Otitis externa	3.2% 4/124 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Otitis media	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Penile infection	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Pharyngitis	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Salivary gland infection	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Sepsis	3.2% 4/124 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Sinusitis	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Skin infection	3.2% 4/124 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	4.8% 2/42 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Small intestine infection	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Upper respiratory infection	3.2% 4/124 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	4.8% 2/42 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Urinary tract infection	5.6% 7/124 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Infections and infestations Wound infection	2.4% 3/124 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Injury, poisoning and procedural complications Dermatitis radiation	0.00% 0/124 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	4.8% 2/42 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Injury, poisoning and procedural complications Fracture	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Injury, poisoning and procedural complications Intraoperative venous injury	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Activated partial thromboplastin time prolonged	3.2% 4/124 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Alanine aminotransferase increased	51.6% 64/124 • Number of events 71 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	28.6% 12/42 • Number of events 14 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Alkaline phosphatase increased	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Aspartate aminotransferase increased	28.2% 35/124 • Number of events 35 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	9.5% 4/42 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Blood bilirubin increased	5.6% 7/124 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Cholesterol high	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Creatinine increased	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/124 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Investigations Fibrinogen decreased	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	2.4% 3/124 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Skin and subcutaneous tissue disorders Pain of skin	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Skin and subcutaneous tissue disorders Purpura	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Skin and subcutaneous tissue disorders Rash acneiform	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Vascular disorders Capillary leak syndrome	0.00% 0/124 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	2.4% 1/42 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Vascular disorders Hypertension	1.6% 2/124 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Vascular disorders Hypotension	3.2% 4/124 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	7.1% 3/42 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Vascular disorders Thromboembolic event	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	7.1% 3/42 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
Vascular disorders Vascular disorders - Other	0.81% 1/124 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.	0.00% 0/42 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: resultsreportingcoordinator@childrensoncologygroup.org

Results disclosure agreements

• Principal investigator is a sponsor employee Must obtain prior sponsor approval.
• Publication restrictions are in place

Restriction type: OTHER