Trial Outcomes & Findings for Lorvotuzumab Mertansine in Treating Younger Patients With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor, or Synovial Sarcoma (NCT NCT02452554)

Last Updated: 2022-01-13

Results Overview

The best response of disease will be examined separately in each stratum. A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and Clopper-Pearson confidence intervals will be constructed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

Up to 18 weeks (6 courses)

Results posted on

2022-01-13

Participant Flow

Each of 6 disease strata enrolled up to 16 patients who were evaluable for the primary response criteria.

Participant milestones

Participant milestones
Measure	Stratum 1: Wims Tumor ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 2: Rhabdomyosarcoma ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 3: Neuroblastoma ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 4: Pleuropulmonary Blastoma ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 5: Malignant Peripheral Nerve Sheath Tumor ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 6: Synovial Sarcoma ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
Overall Study STARTED	17	17	12	1	5	10
Overall Study COMPLETED	0	0	1	0	0	1
Overall Study NOT COMPLETED	17	17	11	1	5	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Stratum 1: Wims Tumor ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 2: Rhabdomyosarcoma ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 3: Neuroblastoma ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 4: Pleuropulmonary Blastoma ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 5: Malignant Peripheral Nerve Sheath Tumor ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 6: Synovial Sarcoma ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
Overall Study Death	2	1	0	0	0	0
Overall Study Lack of Efficacy	13	14	9	1	5	8
Overall Study Physician Decision	0	1	0	0	0	0
Overall Study Withdrawal by Subject	1	0	2	0	0	1
Overall Study Ineligible	0	1	0	0	0	0
Overall Study Never Received Treatment	1	0	0	0	0	0

Baseline Characteristics

Lorvotuzumab Mertansine in Treating Younger Patients With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor, or Synovial Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stratum 1: Wims Tumor n=17 Participants ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 2: Rhabdomyosarcoma n=17 Participants ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 3: Neuroblastoma n=12 Participants ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 4: Pleuropulmonary Blastoma n=1 Participants ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 5: Malignant Peripheral Nerve Sheath Tumor n=5 Participants ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 6: Synovial Sarcoma n=10 Participants ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	13 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=10 Participants	44 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	10 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=10 Participants	18 Participants n=115 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Continuous	12.61 Years STANDARD_DEVIATION 6.48 • n=5 Participants	18.43 Years STANDARD_DEVIATION 5.28 • n=7 Participants	7.78 Years STANDARD_DEVIATION 1.94 • n=5 Participants	3.69 Years STANDARD_DEVIATION NA • n=4 Participants	12.96 Years STANDARD_DEVIATION 4.29 • n=21 Participants	17.37 Years STANDARD_DEVIATION 4.59 • n=10 Participants	13.2 Years STANDARD_DEVIATION 6.37 • n=115 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=10 Participants	27 Participants n=115 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=10 Participants	35 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	8 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	9 Participants n=10 Participants	51 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	9 Participants n=115 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=10 Participants	43 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	8 Participants n=115 Participants

PRIMARY outcome

Timeframe: Up to 18 weeks (6 courses)

Population: 2 participants were excluded from analysis; 1 participant never received treatment and 1 participant was ineligible, also never receiving treatment.

Outcome measures

Outcome measures
Measure	Stratum 1: Wims Tumor n=16 Participants ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 2: Rhabdomyosarcoma n=16 Participants ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 3: Neuroblastoma n=12 Participants ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 4: Pleuropulmonary Blastoma n=1 Participants ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 5: Malignant Peripheral Nerve Sheath Tumor n=5 Participants ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 6: Synovial Sarcoma n=10 Participants ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1	0.00 Percent of participants Interval 0.0 to 20.59	6.25 Percent of participants Interval 0.16 to 30.23	0.00 Percent of participants Interval 0.0 to 26.46	0.00 Percent of participants Interval 0.0 to 97.5	0.00 Percent of participants Interval 0.0 to 52.18	0.00 Percent of participants Interval 0.0 to 30.85

PRIMARY outcome

Timeframe: Up to 12 months (17 courses)

Population: 203 treatment-cycles were reported for the analysis. 2 participants were excluded from analysis;1 participant never received treatment and 1 participant was ineligible, also never receiving treatment.

Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade for toxicities with Possible, Probable, or Definite attribution to the study drug. Tables will summarize incidence by cycle.

Outcome measures

Outcome measures
Measure	Stratum 1: Wims Tumor n=203 Treatment Cycles ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 2: Rhabdomyosarcoma ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 3: Neuroblastoma ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 4: Pleuropulmonary Blastoma ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 5: Malignant Peripheral Nerve Sheath Tumor ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 6: Synovial Sarcoma ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Dental caries: Grade 3	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Dental caries: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Peripheral motor neuropathy: Grade 3	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Anemia: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Anemia: Grade 3	2 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Anemia: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Anemia: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Colonic fistula: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Colonic fistula: Grade 3	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Colonic fistula: Grade 4	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Colonic fistula: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Colonic perforation: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Colonic perforation: Grade 3	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Colonic perforation: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Colonic perforation: Grade 5	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Dental caries: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Dental caries: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Nausea: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Nausea: Grade 3	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Nausea: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Nausea: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Vomiting: Grade 2	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Vomiting: Grade 3	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Vomiting: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Vomiting: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Tooth infection: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Tooth infection: Grade 3	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Tooth infection: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Tooth infection: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Alanine aminotransferase increased: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Alanine aminotransferase increased: Grade 3	3 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Alanine aminotransferase increased: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Alanine aminotransferase increased: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Aspartate aminotransferase increased: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Aspartate aminotransferase increased: Grade 3	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Aspartate aminotransferase increased: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Aspartate aminotransferase increased: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Lymphocyte count decreased: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Lymphocyte count decreased: Grade 3	2 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Lymphocyte count decreased: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Lymphocyte count decreased: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hyperglycemia: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hyperglycemia: Grade 3	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hyperglycemia: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hyperglycemia: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hyperuricemia: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hyperuricemia: Grade 3	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hyperuricemia: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hyperuricemia: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hypokalemia: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hypokalemia: Grade 3	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hypokalemia: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hypokalemia: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hypophosphatemia: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hypophosphatemia: Grade 3	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hypophosphatemia: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Hypophosphatemia: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Headache: Grade 2	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Headache: Grade 3	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Headache: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Headache: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Peripheral motor neuropathy: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Peripheral motor neuropathy: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Peripheral motor neuropathy: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Peripheral sensory neuropathy: Grade 2	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Peripheral sensory neuropathy: Grade 3	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Peripheral sensory neuropathy: Grade 4	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 Peripheral sensory neuropathy: Grade 5	0 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 All Reportable AEs: Grade 2	2 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 All Reportable AEs: Grade 3	18 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 All Reportable AEs: Grade 4	1 Treatment cycles	—	—	—	—	—
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0 All Reportable AEs: Grade 5	1 Treatment cycles	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-treatment, end of infusion, and 2, 6, 24, 48, and 96 hours after end of infusion on day 1 of course 1, and pre-treatment, end of infusion, and 2 and 6 hours after end of infusion on day 8 of course 1

A descriptive analysis of PK parameters of lorvotuzumab mertansine will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit). Analyses will be descriptive and exploratory and hypotheses generating in nature.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 and 8 of course 1 prior to lorvotuzumab mertansine

The association between CD56+ expression and response will be evaluated using the exact conditional test of proportions (Fisher?s Exact test). Analyses will be descriptive and exploratory and hypotheses generating in nature.

Outcome measures

Outcome data not reported

Adverse Events

Stratum 1: Wims Tumor

Serious events: 7 serious events

Other events: 5 other events

Deaths: 10 deaths

Stratum 2: Rhabdomyosarcoma

Serious events: 8 serious events

Other events: 4 other events

Deaths: 11 deaths

Stratum 3: Neuroblastoma

Serious events: 1 serious events

Other events: 4 other events

Deaths: 4 deaths

Stratum 4: Pleuropulmonary Blastoma

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Stratum 5: Malignant Peripheral Nerve Sheath Tumor

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Stratum 6: Synovial Sarcoma

Serious events: 3 serious events

Other events: 4 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Stratum 1: Wims Tumor n=16 participants at risk ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 2: Rhabdomyosarcoma n=16 participants at risk ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 3: Neuroblastoma n=12 participants at risk ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 4: Pleuropulmonary Blastoma n=1 participants at risk ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 5: Malignant Peripheral Nerve Sheath Tumor n=5 participants at risk ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 6: Synovial Sarcoma n=10 participants at risk ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
Gastrointestinal disorders Abdominal pain	12.5% 2/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	12.5% 2/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Investigations Alanine aminotransferase increased	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	10.0% 1/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Investigations Aspartate aminotransferase increased	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Musculoskeletal and connective tissue disorders Back pain	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Gastrointestinal disorders Colonic fistula	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Gastrointestinal disorders Colonic perforation	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Investigations Creatinine increased	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
General disorders Death NOS	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Metabolism and nutrition disorders Dehydration	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	12.5% 2/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Gastrointestinal disorders Dental caries	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	8.3% 1/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Nervous system disorders Headache	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	10.0% 1/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Gastrointestinal disorders Nausea	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	10.0% 1/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	12.5% 2/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	12.5% 2/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
General disorders Pain	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Respiratory, thoracic and mediastinal disorders Pleural effusion	18.8% 3/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	10.0% 1/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Infections and infestations Sepsis	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Gastrointestinal disorders Vomiting	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	20.0% 2/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Infections and infestations Tooth infection	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	8.3% 1/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Eye disorders Optic nerve disorder	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Renal and urinary disorders Acute kidney injury	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.

Other adverse events

Other adverse events
Measure	Stratum 1: Wims Tumor n=16 participants at risk ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 2: Rhabdomyosarcoma n=16 participants at risk ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 3: Neuroblastoma n=12 participants at risk ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 4: Pleuropulmonary Blastoma n=1 participants at risk ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 5: Malignant Peripheral Nerve Sheath Tumor n=5 participants at risk ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles	Stratum 6: Synovial Sarcoma n=10 participants at risk ADVL1522 Dose Level 1: IMGN901 110 mg/m2/IV over 1-1.5 hours on Days 1 and 8 every 21 days, repeatable up to 17 cycles
Gastrointestinal disorders Abdominal pain	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	100.0% 1/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Investigations Alanine aminotransferase increased	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	8.3% 1/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Blood and lymphatic system disorders Anemia	12.5% 2/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	8.3% 1/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Metabolism and nutrition disorders Anorexia	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	100.0% 1/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Infections and infestations Catheter related infection	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	8.3% 1/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Metabolism and nutrition disorders Dehydration	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	100.0% 1/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	100.0% 1/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
General disorders Fatigue	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
General disorders Fever	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	10.0% 1/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	8.3% 1/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	8.3% 1/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Vascular disorders Hypertension	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	100.0% 1/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Reproductive system and breast disorders Irregular menstruation	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Investigations Lymphocyte count decreased	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	18.8% 3/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	20.0% 2/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Gastrointestinal disorders Nausea	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	100.0% 1/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	10.0% 1/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	10.0% 1/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
Investigations Weight loss	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	20.0% 1/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.
General disorders Non-cardiac chest pain	6.2% 1/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/16 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/12 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/1 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/5 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.	0.00% 0/10 • While patients were on Protocol Therapy: Up to 17, 28-day cycles AE reporting is collected routinely using case report forms. The SAE table reflects NCI CTCAEs submitted by the institution, via expedited reporting (NCI AdEERs/CAeRs). The "AE Other" table reflects all CTCAEs collected; excludes those reported as SAEs. Patients who did not receive treatment before being take off study were not included in the AE tables; per protocol, AE data was not collected for those patients. Ineligible patients were excluded from both the AE and All-Cause Mortality tables.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER