Trial Outcomes & Findings for Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma (NCT NCT01041638)

NCT ID: NCT01041638

Last Updated: 2021-08-17

Results Overview

Designed to collect comprehensive safety/toxicity data, as well as additional efficacy data for the immunotherapy. To address the primary objective, descriptive analyses summarizing the number and type of AEs will be performed. The percentage of patients reporting each unacceptable (Grade 3 or higher) CTC toxicity code, tabulated by course, are reported.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 105 participants
• Primary outcome timeframe: Up to 6 courses of therapy
• Results posted on: 2021-08-17

Participant Flow

Participant milestones

Measure	Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: \> 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	105
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Measure	Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: \> 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Study Adverse Event	4
Overall Study Death	1
Overall Study Lack of Efficacy	7
Overall Study Physician Decision	4
Overall Study Withdrawal by Subject	11

Baseline Characteristics

Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma

Baseline characteristics by cohort

Measure	Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin n=105 Participants Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: \> 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Age, Continuous	4.1 years n=5 Participants
Age, Categorical <=18 years	103 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	82 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	87 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants
Region of Enrollment United States	105 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 courses of therapy

Population: There was one patient that did not receive treatment, represented on the baseline form as "withdrawal by patient", not included in outcome measure tabulation.

Designed to collect comprehensive safety/toxicity data, as well as additional efficacy data for the immunotherapy. To address the primary objective, descriptive analyses summarizing the number and type of AEs will be performed. The percentage of patients reporting each unacceptable (Grade 3 or higher) CTC toxicity code, tabulated by course, are reported.

Outcome measures

Measure	Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin n=104 Participants Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: \> 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Abdominal pain (10300), course 1	17.3077 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Abdominal pain (10300), course 2	5.0000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Abdominal pain (10300), course 3	6.1224 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Abdominal pain (10300), course 4	4.4444 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Abdominal pain (10300), course 5	5.6818 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Abdominal pain (10300), course 6	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Allergic reaction (12000), Course 1	1.92308 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Allergic reaction (12000), Course 2	5.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Allergic reaction (12000), Course 3	3.06122 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Allergic reaction (12000), Course 4	2.22222 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Allergic reaction (12000), Course 5	1.13636 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Allergic reaction (12000), Course 6	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Anal pain (12800), Course 1	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Anal pain (12800), Course 2	1.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Anal pain (12800), Course 3	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Anal pain (12800), Course 4	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Anal pain (12800), Course 5	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Anal pain (12800), Course 6	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Anaphylaxis (13100), Course 1	0.96154 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Anaphylaxis (13100), Course 2	4.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Anaphylaxis (13100), Course 3	1.02041 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Anaphylaxis (13100), Course 4	3.33333 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Anaphylaxis (13100), Course 5	1.13636 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Anaphylaxis (13100), Course 6	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Back pain (16200), Course 1	4.80769 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Back pain (16200), Course 2	5.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Back pain (16200), Course 3	3.06122 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Back pain (16200), Course 4	3.33333 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Back pain (16200), Course 5	4.54545 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Back pain (16200), Course 6	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Capillary leak syndrome (19800) - Course 1	0.96154 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Capillary leak syndrome (19800) - Course 2	4.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Capillary leak syndrome (19800) - Course 3	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Capillary leak syndrome (19800) - Course 4	2.22222 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Capillary leak syndrome (19800) - Course 5	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Capillary leak syndrome (19800) - Course 6	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Chest wall pain (21400) - Course 1	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Chest wall pain (21400) - Course 2	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Chest wall pain (21400) - Course 3	1.02041 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Chest wall pain (21400) - Course 4	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Chest wall pain (21400) - Course 5	1.13636 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Chest wall pain (21400) - Course 6	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Fever (33900) - Course 1	21.1538 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Fever (33900) - Course 2	58.0000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Fever (33900) - Course 3	6.1224 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Fever (33900) - Course 4	31.1111 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Fever (33900) - Course 5	4.5455 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Fever (33900) - Course 6	1.2346 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Flank pain (34200) - Course 1	0.96154 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Flank pain (34200) - Course 2	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Flank pain (34200) - Course 3	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Flank pain (34200) - Course 4	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Flank pain (34200) - Course 5	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Flank pain (34200) - Course 6	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Hypotension (43600) - Course 1	9.6154 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Hypotension (43600) - Course 2	17.0000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Hypotension (43600) - Course 3	4.0816 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Hypotension (43600) - Course 4	14.4444 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Hypotension (43600) - Course 5	7.9545 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Hypotension (43600) - Course 6	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Neck pain (57800) - Course 1	0.96154 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Neck pain (57800) - Course 2	3.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Neck pain (57800) - Course 3	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Neck pain (57800) - Course 4	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Neck pain (57800) - Course 5	1.13636 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Neck pain (57800) - Course 6	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Non-cardiac chest pain (58600) - Course 1	0.96154 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Non-cardiac chest pain (58600) - Course 2	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Non-cardiac chest pain (58600) - Course 3	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Non-cardiac chest pain (58600) - Course 4	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Non-cardiac chest pain (58600) - Course 5	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Non-cardiac chest pain (58600) - Course 6	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Pain (60600) - Course 1	23.0769 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Pain (60600) - Course 2	16.0000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Pain (60600) - Course 3	13.2653 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Pain (60600) - Course 4	20.0000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Pain (60600) - Course 5	11.3636 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Pain (60600) - Course 6	1.2346 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Pain in extremity (60700) - Course 1	4.80769 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Pain in extremity (60700) - Course 2	4.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Pain in extremity (60700) - Course 3	3.06122 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Pain in extremity (60700) - Course 4	6.66667 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Pain in extremity (60700) - Course 5	2.27273 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Pain in extremity (60700) - Course 6	1.23457 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Peripheral sensory neuropathy (64100) - Course 1	0.96154 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Peripheral sensory neuropathy (64100) - Course 2	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Peripheral sensory neuropathy (64100) - Course 3	1.02041 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Peripheral sensory neuropathy (64100) - Course 4	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Peripheral sensory neuropathy (64100) - Course 5	0.00000 percentage of participants
Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). Peripheral sensory neuropathy (64100) - Course 6	0.00000 percentage of participants

SECONDARY outcome

Timeframe: From enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death, or until last contact if no event occurred, up to 3 years

Population: All eligible patients.

Event-free Survival (EFS) for all eligible patients enrolled on the study

Outcome measures

Measure

Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin n=105 Participants Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: \> 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Event-free Survival (EFS)

67.6 percentage Interval 58.2 to 77.0

SECONDARY outcome

Timeframe: From enrollment until death, or until last contact with the patient, up to 3 years

Population: All eligible patients

Overall Survival (OS) for all eligible patients enrolled on the study

Outcome measures

Measure

Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin n=105 Participants Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: \> 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Overall Survival (OS)

79.1 percentage Interval 70.9 to 87.3

Adverse Events

Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin

Serious events: 103 serious events

Other events: 104 other events

Deaths: 0 deaths

Serious adverse events

Measure	Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin n=104 participants at risk Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: \> 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Ear and labyrinth disorders 28000-Ear pain	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Ear and labyrinth disorders 38900-Hearing impaired	8.7% 9/104 • Number of events 9 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 10300-Abdominal pain	20.2% 21/104 • Number of events 56 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Blood and lymphatic system disorders 13200-Anemia	62.5% 65/104 • Number of events 148 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Blood and lymphatic system disorders 18100-Bone marrow hypocellular	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Blood and lymphatic system disorders 33300-Febrile neutropenia	5.8% 6/104 • Number of events 9 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Cardiac disorders 20000-Cardiac arrest	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Cardiac disorders 74500-Sinus tachycardia	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 12800-Anal pain	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 22100-Colitis	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 22400-Colonic obstruction	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 25700-Diarrhea	14.4% 15/104 • Number of events 20 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 27600-Dysphagia	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 44200-Ileal obstruction	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 53900-Malabsorption	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 55600-Mucositis oral	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 57600-Nausea	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 81900-Typhlitis	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 87900-Vomiting	3.8% 4/104 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 28200-Edema face	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 33900-Fever	66.3% 69/104 • Number of events 204 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 37200-General disorders and administration site conditions - Other	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 48700-Irritability	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 58600-Non-cardiac chest pain	0.96% 1/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 60600-Pain	44.2% 46/104 • Number of events 134 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Immune system disorders 12000-Allergic reaction	8.7% 9/104 • Number of events 13 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Immune system disorders 13100-Anaphylaxis	8.7% 9/104 • Number of events 11 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Immune system disorders 24400-Cytokine release syndrome	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 20500-Catheter related infection	31.7% 33/104 • Number of events 63 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 25600-Device related infection	3.8% 4/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 29500-Enterocolitis infectious	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 44800-Infections and infestations - Other	15.4% 16/104 • Number of events 23 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 53100-Lung infection	4.8% 5/104 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 60100-Otitis media	1.9% 2/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 73700-Sepsis	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 75200-Skin infection	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 76000-Small intestine infection	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 82300-Upper respiratory infection	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 83100-Urinary tract infection	3.8% 4/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Injury, poisoning and procedural complications 86400-Vascular access complication	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 10900-Activated partial thromboplastin time prolonged	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 11600-Alanine aminotransferase increased	23.1% 24/104 • Number of events 49 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 11800-Alkaline phosphatase increased	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 15000-Aspartate aminotransferase increased	10.6% 11/104 • Number of events 17 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 17400-Blood bilirubin increased	1.9% 2/104 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 24100-Creatinine increased	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 37500-GGT increased	10.6% 11/104 • Number of events 27 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 53700-Lymphocyte count decreased	75.0% 78/104 • Number of events 339 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 53800-Lymphocyte count increased	3.8% 4/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 58300-Neutrophil count decreased	52.9% 55/104 • Number of events 193 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 65800-Platelet count decreased	55.8% 58/104 • Number of events 355 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 83600-Urine output decreased	4.8% 5/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 88200-Weight gain	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 88300-Weight loss	3.8% 4/104 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 88500-White blood cell decreased	24.0% 25/104 • Number of events 82 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 10700-Acidosis	4.8% 5/104 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 13500-Anorexia	22.1% 23/104 • Number of events 25 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 24700-Dehydration	4.8% 5/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 41300-Hypercalcemia	4.8% 5/104 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 41400-Hyperglycemia	10.6% 11/104 • Number of events 13 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 41600-Hyperkalemia	6.7% 7/104 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 41700-Hypermagnesemia	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 41800-Hypernatremia	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 42400-Hypertriglyceridemia	1.9% 2/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 42600-Hypoalbuminemia	8.7% 9/104 • Number of events 11 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 42700-Hypocalcemia	4.8% 5/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 42900-Hypoglycemia	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 43100-Hypokalemia	49.0% 51/104 • Number of events 117 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 43300-Hyponatremia	40.4% 42/104 • Number of events 63 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 43500-Hypophosphatemia	16.3% 17/104 • Number of events 17 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 16200-Back pain	9.6% 10/104 • Number of events 23 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 21400-Chest wall pain	0.96% 1/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 34200-Flank pain	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 57800-Neck pain	3.8% 4/104 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 60700-Pain in extremity	16.3% 17/104 • Number of events 34 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 15300-Ataxia	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 25300-Depressed level of consciousness	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 38800-Headache	5.8% 6/104 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 42000-Hypersomnia	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 58200-Neuralgia	7.7% 8/104 • Number of events 23 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 59000-Oculomotor nerve disorder	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 63900-Peripheral motor neuropathy	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 64100-Peripheral sensory neuropathy	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 76700-Somnolence	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders 11400-Agitation	3.8% 4/104 • Number of events 9 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders 13700-Anxiety	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders 25000-Delirium	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders 38500-Hallucinations	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Renal and urinary disorders 11100-Acute kidney injury	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Renal and urinary disorders 68300-Proteinuria	0.96% 1/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Renal and urinary disorders 83000-Urinary retention	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 14100-Apnea	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 19300-Bronchospasm	3.8% 4/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 23800-Cough	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 27800-Dyspnea	11.5% 12/104 • Number of events 25 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 43900-Hypoxia	27.9% 29/104 • Number of events 58 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 68700-Pulmonary edema	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 71600-Respiratory thoracic and mediastinal disorders - Other	1.9% 2/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 78100-Stridor	3.8% 4/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 88400-Wheezing	1.9% 2/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 26200-Dry skin	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 63600-Periorbital edema	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 68400-Pruritus	2.9% 3/104 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 69700-Rash maculo-papular	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 84100-Urticaria	10.6% 11/104 • Number of events 22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Surgical and medical procedures 79000-Surgical and medical procedures - Other	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Vascular disorders 19800-Capillary leak syndrome	6.7% 7/104 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Vascular disorders 42100-Hypertension	3.8% 4/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Vascular disorders 43600-Hypotension	31.7% 33/104 • Number of events 67 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.

Other adverse events

Measure	Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin n=104 participants at risk Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: \> 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Investigations 37500-GGT increased	19.2% 20/104 • Number of events 87 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 39400-Hemoglobin increased	8.7% 9/104 • Number of events 29 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 45800-INR increased	4.8% 5/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Blood and lymphatic system disorders 13200-Anemia	95.2% 99/104 • Number of events 1181 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Blood and lymphatic system disorders 17200-Blood and lymphatic system disorders - Other	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Blood and lymphatic system disorders 18100-Bone marrow hypocellular	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Blood and lymphatic system disorders 25800-Disseminated intravascular coagulation	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Cardiac disorders 20100-Cardiac disorders - Other	5.8% 6/104 • Number of events 16 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Cardiac disorders 21300-Chest pain - cardiac	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Cardiac disorders 61000-Palpitations	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Cardiac disorders 63100-Pericardial effusion	1.9% 2/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Cardiac disorders 74200-Sinus bradycardia	6.7% 7/104 • Number of events 18 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Cardiac disorders 74500-Sinus tachycardia	81.7% 85/104 • Number of events 740 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Cardiac disorders 78900-Supraventricular tachycardia	2.9% 3/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Cardiac disorders 81400-Tricuspid valve disease	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Ear and labyrinth disorders 27900-Ear and labyrinth disorders - Other	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Ear and labyrinth disorders 28000-Ear pain	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Ear and labyrinth disorders 31600-External ear pain	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Ear and labyrinth disorders 38900-Hearing impaired	9.6% 10/104 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Endocrine disorders 11200-Adrenal insufficiency	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Endocrine disorders 29200-Endocrine disorders - Other	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Endocrine disorders 41900-Hyperparathyroidism	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Endocrine disorders 42200-Hyperthyroidism	4.8% 5/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Endocrine disorders 43400-Hypoparathyroidism	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Endocrine disorders 43800-Hypothyroidism	4.8% 5/104 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Eye disorders 17800-Blurred vision	4.8% 5/104 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Eye disorders 23200-Conjunctivitis	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Eye disorders 26000-Dry eye	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Eye disorders 31900-Eye disorders - Other	12.5% 13/104 • Number of events 14 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Eye disorders 32100-Eye pain	4.8% 5/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Eye disorders 32200-Eyelid function disorder	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Eye disorders 59300-Optic nerve disorder	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Eye disorders 61900-Papilledema	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Eye disorders 65600-Photophobia	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Eye disorders 73200-Scleral disorder	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 10100-Abdominal distension	13.5% 14/104 • Number of events 27 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 10300-Abdominal pain	67.3% 70/104 • Number of events 284 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 12800-Anal pain	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 17100-Bloating	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 21200-Cheilitis	9.6% 10/104 • Number of events 14 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 22100-Colitis	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 23400-Constipation	34.6% 36/104 • Number of events 72 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 25700-Diarrhea	57.7% 60/104 • Number of events 203 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 26100-Dry mouth	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 27500-Dyspepsia	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 27600-Dysphagia	3.8% 4/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 29400-Enterocolitis	3.8% 4/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 34400-Flatulence	4.8% 5/104 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 36400-Gastritis	5.8% 6/104 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 36500-Gastroesophageal reflux disease	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 36700-Gastrointestinal disorders - Other	4.8% 5/104 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 36900-Gastrointestinal pain	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 37600-Gingival pain	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 39800-Hemorrhoidal hemorrhage	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 55600-Mucositis oral	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 57600-Nausea	52.9% 55/104 • Number of events 188 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 59700-Oral pain	3.8% 4/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 70800-Rectal ulcer	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 77900-Stomach pain	6.7% 7/104 • Number of events 13 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 80200-Toothache	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Gastrointestinal disorders 87900-Vomiting	62.5% 65/104 • Number of events 309 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 21500-Chills	20.2% 21/104 • Number of events 34 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 28200-Edema face	53.8% 56/104 • Number of events 110 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 28300-Edema limbs	34.6% 36/104 • Number of events 61 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 28400-Edema trunk	4.8% 5/104 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 32500-Facial pain	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 33200-Fatigue	32.7% 34/104 • Number of events 73 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 33900-Fever	98.1% 102/104 • Number of events 1117 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 34600-Flu like symptoms	1.9% 2/104 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 35000-Gait disturbance	2.9% 3/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 37200-General disorders and administration site conditions - Other	3.8% 4/104 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 43700-Hypothermia	0.96% 1/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 45000-Infusion related reaction	3.8% 4/104 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 45200-Injection site reaction	15.4% 16/104 • Number of events 23 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 48700-Irritability	31.7% 33/104 • Number of events 74 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 52800-Localized edema	9.6% 10/104 • Number of events 14 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 54000-Malaise	3.8% 4/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 58600-Non-cardiac chest pain	5.8% 6/104 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
General disorders 60600-Pain	78.8% 82/104 • Number of events 746 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Immune system disorders 12000-Allergic reaction	31.7% 33/104 • Number of events 123 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Immune system disorders 24400-Cytokine release syndrome	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 18800-Bronchial infection	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 20500-Catheter related infection	4.8% 5/104 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 23300-Conjunctivitis infective	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 29500-Enterocolitis infectious	8.7% 9/104 • Number of events 13 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 30400-Esophageal infection	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 44800-Infections and infestations - Other	20.2% 21/104 • Number of events 28 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 53100-Lung infection	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 55500-Mucosal infection	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 57200-Nail infection	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 60100-Otitis media	3.8% 4/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 62000-Papulopustular rash	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 62200-Paronychia	0.96% 1/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 65200-Pharyngitis	2.9% 3/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 72600-Rhinitis infective	2.9% 3/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 74600-Sinusitis	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 75200-Skin infection	5.8% 6/104 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 76000-Small intestine infection	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 82300-Upper respiratory infection	8.7% 9/104 • Number of events 11 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Infections and infestations 83100-Urinary tract infection	5.8% 6/104 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Injury, poisoning and procedural complications 19400-Bruising	7.7% 8/104 • Number of events 9 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Injury, poisoning and procedural complications 25500-Dermatitis radiation	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Injury, poisoning and procedural complications 45700-Injury poisoning and procedural complications - Other	1.9% 2/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Injury, poisoning and procedural complications 66800-Postoperative hemorrhage	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Injury, poisoning and procedural complications 86400-Vascular access complication	7.7% 8/104 • Number of events 13 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 10900-Activated partial thromboplastin time prolonged	7.7% 8/104 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 11600-Alanine aminotransferase increased	86.5% 90/104 • Number of events 507 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 11800-Alkaline phosphatase increased	19.2% 20/104 • Number of events 64 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 15000-Aspartate aminotransferase increased	87.5% 91/104 • Number of events 399 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 17400-Blood bilirubin increased	14.4% 15/104 • Number of events 40 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 21700-Cholesterol high	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 24100-Creatinine increased	29.8% 31/104 • Number of events 137 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 28700-Electrocardiogram QT corrected interval prolonged	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 48400-Investigations - Other	2.9% 3/104 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 53700-Lymphocyte count decreased	83.7% 87/104 • Number of events 904 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 53800-Lymphocyte count increased	3.8% 4/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 58300-Neutrophil count decreased	64.4% 67/104 • Number of events 376 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 65800-Platelet count decreased	93.3% 97/104 • Number of events 780 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 88200-Weight gain	53.8% 56/104 • Number of events 227 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 88300-Weight loss	20.2% 21/104 • Number of events 54 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Investigations 88500-White blood cell decreased	85.6% 89/104 • Number of events 737 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 10700-Acidosis	2.9% 3/104 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 13500-Anorexia	30.8% 32/104 • Number of events 84 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 24700-Dehydration	12.5% 13/104 • Number of events 16 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 41300-Hypercalcemia	25.0% 26/104 • Number of events 48 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 41400-Hyperglycemia	58.7% 61/104 • Number of events 195 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 41600-Hyperkalemia	33.7% 35/104 • Number of events 71 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 41700-Hypermagnesemia	16.3% 17/104 • Number of events 52 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 41800-Hypernatremia	11.5% 12/104 • Number of events 18 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 42400-Hypertriglyceridemia	80.8% 84/104 • Number of events 205 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 42500-Hyperuricemia	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 42600-Hypoalbuminemia	97.1% 101/104 • Number of events 890 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 42700-Hypocalcemia	92.3% 96/104 • Number of events 579 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 42900-Hypoglycemia	41.3% 43/104 • Number of events 95 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 43100-Hypokalemia	81.7% 85/104 • Number of events 392 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 43200-Hypomagnesemia	39.4% 41/104 • Number of events 119 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 43300-Hyponatremia	91.3% 95/104 • Number of events 524 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 43500-Hypophosphatemia	66.3% 69/104 • Number of events 211 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Metabolism and nutrition disorders 54900-Metabolism and nutrition disorders - Other	1.9% 2/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 14700-Arthralgia	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 16200-Back pain	24.0% 25/104 • Number of events 70 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 18200-Bone pain	4.8% 5/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 19700-Buttock pain	3.8% 4/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 21400-Chest wall pain	5.8% 6/104 • Number of events 22 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 37300-Generalized muscle weakness	1.9% 2/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 49800-Joint range of motion decreased	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 55900-Muscle weakness lower limb	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 56300-Musculoskeletal and connective tissue disorder - Other	1.9% 2/104 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 56500-Myalgia	9.6% 10/104 • Number of events 11 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 57800-Neck pain	13.5% 14/104 • Number of events 32 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Musculoskeletal and connective tissue disorders 60700-Pain in extremity	46.2% 48/104 • Number of events 155 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 11500-Akathisia	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 22000-Cognitive disturbance	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 22800-Concentration impairment	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 25300-Depressed level of consciousness	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 25900-Dizziness	2.9% 3/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 38800-Headache	29.8% 31/104 • Number of events 76 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 42000-Hypersomnia	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 51800-Lethargy	4.8% 5/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 54400-Memory impairment	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 54500-Meningismus	0.96% 1/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 55400-Movements involuntary	3.8% 4/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 58100-Nervous system disorders - Other	1.9% 2/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 58200-Neuralgia	4.8% 5/104 • Number of events 13 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 58700-Nystagmus	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 59000-Oculomotor nerve disorder	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 62100-Paresthesia	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 64100-Peripheral sensory neuropathy	10.6% 11/104 • Number of events 16 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 73600-Seizure	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 76700-Somnolence	6.7% 7/104 • Number of events 7 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Nervous system disorders 81300-Tremor	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Pregnancy, puerperium and perinatal conditions 67200-Premature delivery	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders 11400-Agitation	23.1% 24/104 • Number of events 40 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders 13700-Anxiety	13.5% 14/104 • Number of events 23 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders 23000-Confusion	6.7% 7/104 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders 25400-Depression	2.9% 3/104 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders 38500-Hallucinations	9.6% 10/104 • Number of events 14 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders 45900-Insomnia	6.7% 7/104 • Number of events 8 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders 54100-Mania	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders 68500-Psychiatric disorders - Other	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Psychiatric disorders 71700-Restlessness	3.8% 4/104 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Renal and urinary disorders 11100-Acute kidney injury	1.9% 2/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Renal and urinary disorders 21800-Chronic kidney disease	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Renal and urinary disorders 39300-Hematuria	34.6% 36/104 • Number of events 93 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Renal and urinary disorders 68300-Proteinuria	41.3% 43/104 • Number of events 144 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Renal and urinary disorders 71000-Renal and urinary disorders - Other	1.9% 2/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Renal and urinary disorders 82800-Urinary frequency	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Renal and urinary disorders 82900-Urinary incontinence	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Renal and urinary disorders 83000-Urinary retention	28.8% 30/104 • Number of events 63 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Renal and urinary disorders 83300-Urinary tract pain	3.8% 4/104 • Number of events 9 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Renal and urinary disorders 83400-Urinary urgency	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Renal and urinary disorders 83500-Urine discoloration	4.8% 5/104 • Number of events 13 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Reproductive system and breast disorders 37400-Genital edema	0.96% 1/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Reproductive system and breast disorders 62600-Pelvic pain	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Reproductive system and breast disorders 62900-Penile pain	1.9% 2/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Reproductive system and breast disorders 71400-Reproductive system and breast disorders - Other	0.96% 1/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Reproductive system and breast disorders 85600-Vaginal inflammation	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 12100-Allergic rhinitis	14.4% 15/104 • Number of events 18 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 15400-Atelectasis	5.8% 6/104 • Number of events 9 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 19000-Bronchial stricture	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 19300-Bronchospasm	9.6% 10/104 • Number of events 16 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 23800-Cough	71.2% 74/104 • Number of events 220 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 27800-Dyspnea	7.7% 8/104 • Number of events 11 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 29700-Epistaxis	3.8% 4/104 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 40700-Hiccups	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 41000-Hoarseness	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 43900-Hypoxia	30.8% 32/104 • Number of events 99 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 51500-Laryngopharyngeal dysesthesia	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 51600-Laryngospasm	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 57500-Nasal congestion	22.1% 23/104 • Number of events 39 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 65300-Pharyngolaryngeal pain	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 65900-Pleural effusion	3.8% 4/104 • Number of events 5 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 66200-Pleuritic pain	0.96% 1/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 66300-Pneumonitis	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 66700-Postnasal drip	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 67600-Productive cough	3.8% 4/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 68700-Pulmonary edema	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 71600-Respiratory thoracic and mediastinal disorders - Other	32.7% 34/104 • Number of events 242 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 72200-Retinoic acid syndrome	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 76200-Sneezing	5.8% 6/104 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 76800-Sore throat	6.7% 7/104 • Number of events 12 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Respiratory, thoracic and mediastinal disorders 88400-Wheezing	16.3% 17/104 • Number of events 37 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 12200-Alopecia	26.9% 28/104 • Number of events 36 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 19500-Bullous dermatitis	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 26200-Dry skin	66.3% 69/104 • Number of events 175 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 29900-Erythema multiforme	7.7% 8/104 • Number of events 11 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 42300-Hypertrichosis	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 57300-Nail loss	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 60900-Palmar-plantar erythrodysesthesia syndrome	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 63600-Periorbital edema	15.4% 16/104 • Number of events 27 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 65700-Photosensitivity	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 68400-Pruritus	59.6% 62/104 • Number of events 223 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 69600-Rash acneiform	4.8% 5/104 • Number of events 6 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 69700-Rash maculo-papular	55.8% 58/104 • Number of events 130 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 74700-Skin and subcutaneous tissue disorders - Other	19.2% 20/104 • Number of events 51 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 74800-Skin atrophy	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 74900-Skin hyperpigmentation	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 75000-Skin hypopigmentation	1.9% 2/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 75100-Skin induration	2.9% 3/104 • Number of events 3 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 75300-Skin ulceration	3.8% 4/104 • Number of events 4 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Skin and subcutaneous tissue disorders 84100-Urticaria	44.2% 46/104 • Number of events 139 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Vascular disorders 19800-Capillary leak syndrome	51.0% 53/104 • Number of events 131 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Vascular disorders 34700-Flushing	7.7% 8/104 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Vascular disorders 41100-Hot flashes	1.9% 2/104 • Number of events 2 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Vascular disorders 42100-Hypertension	53.8% 56/104 • Number of events 406 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Vascular disorders 43600-Hypotension	77.9% 81/104 • Number of events 768 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Vascular disorders 79600-Thromboembolic event	0.96% 1/104 • Number of events 1 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.
Vascular disorders 86500-Vascular disorders - Other	2.9% 3/104 • Number of events 10 SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: resultsreportingcoordinator@childrensoncologygroup.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60